oo ao DEPARTMENT OF HEALTH & HUMAN SERVICES Public Haak Service ood ane rug Admieistration (Canter for Devices an Radiological Haak AUG 1 2008 oct, MO S0860 VIA FEDERAL EXPRESS Scott Beggins Vice President, Global Regulatory Affairs One Edwards Way Irvine, CA 92614 Dear Mr. Begins: Ithas come to our attention that you are currently marketing the Myxo ETlogix Ring, as described on your website (hitp:/www edwards com/products/rings/myxo htm), which is intended to correct mitral valve insufficiency in patients with myxomatous disease. The Myxo ETlogix Ring appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act. We have conducted a review of our files, including our files on your cleared annuloplasty rings, and have been unable to identify any Food and Drug Administrative (FDA) premarket notification (510(k)) or Investigational Device Exemption (IDE) application for the Myxo ETlogix Ring. We request that you provide us with the 510(K) or IDE number for the Myxo ETlogix Ring. If you do not believe that you are required to obtain 510(k) or IDE approval for the Myxo ETlogix Ring, please provide us with the basis for that determination. ‘Thank you in advance for your prompt response. Please direct your response (0 William MacFarland, HFZ-341 Office of Compliance 9200 Corporate Blvd. Rockvitle, MD 20850 If you have questions relating to this matter, please feel free to call me at 240-276-0293, or log onto our web site at www. fda. gov for general information relating to FDA device requirements. Sincerely SSP William C. MacFarland Acting Chief, Cardiovascular and Neurological Device Branch Division of Enforcement A. Office of Compliance Center for Devices and Radiological tfealth| Edwards URGENT NOTICE PRODUCT RETURN MYXO ETLOGIX ANNULOPLASTY RING Model 5109, All Sizes, All Lots. December 5, 2008 Attention: RiskManagement ce: Department of Cardlac Surgery Re: Myxo ETlogix Annuloplasty Ring, Model #'s 5100M26, 5100M28, §100M30, 5100M32, 5100M34, ‘5100M36, 5100M38, and 5100M40, Sizes 26mm - 40mm Dear Valued Customer, ‘This request to return all Myxo rings to Edwards has been initiated because the FDA questioned the appropriateness of the product's name and disagreed with the company's conclusion that a 510(k) premarket notification was unnecessary prior to distributing the product. These decisions were not prompted by any product performance issues, but instead reflect the company’s commitment to being responsive to the FDA. As a result, Edwards is changing the name of the device and has submitted a 510(k) application to the FDA, which is currently under review. ‘Should you receive questions about the Myxo ring from patients, please inform them that these decisions were not prompted by product performance issues. If you or any of your patients would like to speak with an Edwards representative, the company would be pleased to make avaliable a member of our medical staff. {All Myxo model sizes (26mm through 40mm) are being collected. The affected product codes are 5100M26, 5100M28, 5100M3O, 5100M32, 5100M34, 5100M36, 5100M38, and 510040. Please check your inventory for any affected product and return all unused product from your stock to Edwards, Please call Edwards Customer Sorvice at 888.870.4012 (6:00 AM PDT to 4:30 PM PDT) to arrange for return of any unused product and obtain information about replacement product. Please retum all unused product to: Edwards Lifesciences LLC Attn: Returned Goods 1212 Alton Parkway Irvine, CA 92614 After you have verified your inventory, please complete the attached Confirmation Form. Please complete and retum this form even if you do not have any affected units at your facility. This wil allow us to verify the completion of ths initiative. Please return the Confirmation Form by FAX to: 800.422.9328, Attention: Myxo Return Coordinator, We sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. Sincerely, Donald E. Bobo, J. Corporate Vice President, Heart Valve Therapy Edwards Lifescionces LLC One Edwards Way» Inne, CA USA 92614 Phone: 849-250 2800» Fax: 948 2502525 + ww edwards.comiD Edwards mo ETloalx Annulopl 1m Response Customer Name Address Contact Name __Contact Tel (__) MYXO RING [check if no MYXO inventory Number of units Product Code Size fate treed S100M26 26mm ——si00M28 ‘2emm _ 510030 30mm ‘5100M32 32mm ‘S100M34 34mm 5100M36 36mm S100M38 38mm ‘510040 40mm RGA No. (person completing this form) Date Please call 888-570-4012 to request an RGA number and if you have any questions. Please fill in the number of units being returned and the RGA number and Fax completed form to the Return Coordinator at 800-422-9329 Note: Please enter a zero “0” or indicate “none” if you have no inventory to return. awards Lifescionces LLC ‘One Edwards Way «vine, CA USA 92514 Phone: 843,250 2800 « Fax 949,250 2525 -wnww.edwards.com3 Edwards URGENT NOTICE PRODUCT RETURN IMR ETLOGIX ANNULOPLASTY RING Model 4100, All Sizes, All Lots December 8, 2008 Attention: Risk Management Department of Cardiac Surgery Re: IMR ETlogix Annuloplasty Ring, Model #'s 4100M24, 4100M26, 4100M28, 4100M30, 4100M32, and 4100M34, Sizes 24mm - 34mm Dear Valued Customer, This request to return all IMR rings to Edwards was voluntarily initiated by the company as a result of its intemal review of all Justification to File letters for its annuloplasty rings. In this context, Edwards decided to submit a new 510(k) pplication to the FDA for the IMR ring, and this submission is currently under review. The decision to submit a 510(k) for the IMR ring was not prompted by any product performance issues, but instead reflects the company's commitment fo be responsive to the FDA, ‘Should you receive questions about the IMR ETlogix ring from patients, please inform them that these decisions were not prompted by product performance issues. If you or any of your patients would like to speak with an Edwards representative, the company would be pleased to make available a member of our medical staf AILIMR ETlogix model sizes (24mm through 34mm) are being collected. The affected product codes are 4100M24, 4100M26, 4100M28, 4100M30, 4100M32, and 4100M36. Please check your inventory for any affected product and retum all unused product from your stock to Edwards. Please call Edwards Customer Service at 888.570.4012 (6:00 AM PDT to 4:30 PM PDT) to arrange for retum of any unused product and obtain information about replacement product. Please retum all unused product to: Edwards Lifesciences LLC ‘Attn: Returned Goods 41212 Alton Parkway Irvine, CA 92614 ‘After you have verified your inventory, please complete the attached Confirmation Form. Please complete and return this form even if you do not have any affected units at your facility. This will allow us to verify the completion of ths initiative. Please return the Confirmation Form by FAX to: 800.422.9329, Attention: IMR ETlogix Return Coordinator. ‘We sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. Sincerely, Donald E. Bobo, Jr Corporate Vice President, Heart Valve Therapy Edwards Lifesciences LLC ‘One Edwards Way «rine, CA USA 92614 Phone: 949250 2500 » Fax 968,250 2525 » wn edwardsiB Edwards ETI iloplasty Ring In order to facilitate the RGA process, please record Serial Numbers prior to contacting Edwards. IMR ETLOGIX RING List Serial Numbers to be returned Poe (or enter “0” or “None” if no stock on hand) 4100M24 4100026 4100M28. ‘4100M30 ‘410032 ‘4100M34 Customer/Hospital Name RGA No. Print Name (person completing this form) Signature Date Please call 888-570-4012 to request an RGA number and if you have any questions. Please fil to the Return Coordinator at 800-422-9329. the serial number(s) of units being returned and the RGA number and Fax completed form Note: Please enter a zero “0” or indicate "None" if you have no inventory to return. Edwards Lifesclonces LLC (One Edwaras Way «Inne, CA USA 92614 Phone: 96920 2500 «Fax: 949.260:2826 win edvards.comHealthCare S 4 a ‘Déan'M. Harrigod © * +" : : dos nt Cn ice Maiiteen’M. Obermeier 3929 Hamilton Ave. Chicago, IL 60620 ‘Dear Ms. Obermeier, ‘You may have seen some recent media reports regarding the Myxo ET Logix 5100 Annuloplasty Ring which you received during your heart surgery at Northwestem Memorial Hospital. I would like to provide you with some perspective regarding this ring and a contact here at Northwestern Memorial should you have additional questions or concerns. ‘Yoitr Surgeon; Patrick’M. McCarthy, MD, Chief, Division of Cardiothoracic Surgery, Co-director of the Bluhm Cardiovascular Institute of Northwestern ‘Memorial Hospital and Heller-Sacks Professor of Surgery at Northwestern University’s Feinberg School of Medicine, is a co-inventor of this ring. “As you are probably aware, Dr. McCarthy is a world-renowned cardiothoracic surgeon. He has ‘published more than 300 papers and two books on matters related to the heart and heart failure, Some news stories have reported allegations that the Myxo ET Logix 5100 ring was experimental and not cleared by the FDA for use. We do not consider this device to be experimental. We have relied upon the manufacturer, Edwards Lifesciences, to follow proper regulatory process to clear the device for market and we have been assured by Edwards that it did so. We believe itis safe and effective with very good results. Thope this letter finds you well. Our organization-wide goal is to provide the Best Patient Experience for each patient and our dedicated staff works hard to ensure that we do so. Please feel free to contact Janice Knuckey or Belinda Rodgers at 312-694-9404 with any questions you may have regarding the ring or your procedure. Sincerely, Qe uelbonese 251 East Huron Street, Suite 3-708, Chicago, Ilinois 60611-2908 312.926.3007 www.nmhorgNorthwestern Memorial® HealthCare een M, Havrson, President and Chief Bxecutive Officer May 8, 2009 Maureen M. Obermeier 8929 Hamilton Ave, Chicago, IL 60620 Dear Ms, Obermeier, Tam pleased to provide you with an update to my January 26, 2009 letter regarding tie Myxo ET Logix 5100 Annuloplasty Ring, which you received during your heart surgery at Northwestern Memorial Hospital. ‘As L explained in my priory Jetter, Edwards Lifesciences, the ring’s manufacturer, had ‘assured us that the ring had gone through the appropriate process for clearance by the Food and Drug Administration (FDA) before making it commercially available, Last fall, Edwards voluntarily submitted the ring for another FDA review process. On ‘Aptil 10, 2009, ufter its review was complete, the FDA determined that the ring is safe and effective, This notice by the FDA officially permits Edwards to once again market the ring, Other than changing the name of the ring to Edwards aBTLogix annuloplasty ring 5100, nothing else about it is different. Your surgeon, Patrick M. McCarthy, MD, chief, Division of Cardiothoracic Surgery, co-director of the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital and Heller-Sacks Professor of Surgery at Northwestern University’s Feinberg School of Medicine, is a co-inventor of this ring. As an innovator and widely acclaimed cardiothoracic surgeon, Dr. McCarthy's contributions to advancing treatment options for patients with heart disease have been signifieaat, ‘We are pleased with the FDA's confirmation and hope this information provides you with additional comfort and confidence about the care you received at Northwestern Memorial, Please feel free to contact Janice Knuckey or Belinda Rodgers at 312-694- 9404 with any questions you may have regarding the ring or your procedure, Sincerely, DiiaLbicni’ S1 Fast Huron Stset, Sue J7ON, Chieago, Wino 60611 9H8 12,026,500 wae nm ong Td Wd2S:18 S202 TT “Une Seb Sb £22 7 ON SNOHd oa- i DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration % Office of the Commissioner Sm October 13, 2016 ‘Nalini M. Rajamannan, M.D. Visiting Scientist Mayo Clinie Most Sacred Heart of Jesus Cardiology and Valvular Institute 703 N. 8° Street Suite 303 Sheboygan, WI 53081 Receipt of email Correspondence dated September 4, 2015; October 1, 2015; November 6, lovember 23, 2015; November 24, 2015; November 25, 2015; November 30, 2015; December 2, 2015; December 6, 2015: and February §, 2016 Dear Dr. Rajamannan: Dr. Robert Califf and Dr. Joanne Less forwarded the above correspondence to the Office of Scientific Integrity within the Office of the Chief Scientist. I construe this correspondence as a request for intemal agency review pursuant to 21 CFR 10.75. The purpose of this letter is to notify you that the Office of the Commissioner is denying your request, under 21 CFR 10.75, for review of a decision made by the Center for Devices and Radiological Health (CDRH). The decision you challenge centered on the dETlogix annuloplasty ring, model $100, and thus the Office of the Commissioner construes this as a request to review CDRH’s decisions related to that device. CDRH denied your request to require notification to relevant patients that FDA had not authorized the device for marketing between 2006 and 2008. In the above correspondence, you also request a safety waming for, and a recall of, the dETlogix annuloplasty ring. Having reviewed the arguments you raise in the above correspondence, the attachments to the above correspondence, and documents from the administrative file, the Office of the Commissioner has determined that additional agency review is not warranted. FDA conducted ‘multiple investigations and inspections related to your allegations regarding the dE Tlogix annuloplasty ring and ensured that the manufacturer obtained clearance to market the annuloplasty ring. As set forth in FDA"s November 5, 2008. letter to Senator Richard ©. Lugar,CDRH provided a reasoned basis for its decision not to notify relevant patients that FDA had not Cleared the GETlogix annuloplasty ring a the time of implantation, Finally, documents in the administrative file indicate that CDRH has previously reviewed the safety profile of the annuloplasty ting based on the concems you raised, ‘We note thatthe above correspondence also briefly mentions the IMR ETlogix annuloplasty fing. You request patient notification with regard tothe use ofthe IMR ETlogix annuloplasty ‘ing from 2003-2005 and a safety warning for, and a recall of, the IMR ETlogix annuloplasty fing. The above correspondence also referenced alleged off-label use of an Atioure device but focused on the dETlogix ring, The Office of the Commissioner does not construe these requests 8s part of the request for review under 21 CFR 10.75 and as such will not address them further. Should you have new information relevant to the safety or efficacy ofthe 4ETIogix annuloplasty ‘ng, IMR ETlogix annuloplasty ring, or an Atricure device that you have not previously Provided to FDA, such information should be provided in writing directly to the CDRH Ombudsman at CORHOmbudsmang@faa hs gov or CDRH-Ombudsman, Center for Devices ané Radiological Heslth, Food and Drag Administration, WO32 Room 4282, 10903 New ‘Hampshire Avenue, Silver Spring, MD 20993, Sincerely, Qe Luciana Borio, M.D. Acting Chief Scientist cc: Robert Califf, M.D. Joanne Less, Ph.D. CDRH Ombudsman George Karavetsos, J.D. Daniel R. Levinson, J.D. Kristina C. Bortor, Ph.D.