fice forthe Protection Norte Lrivesity tResearch Subjects 5D Lae Share Dive ‘alt Bisa, eee hia, tons 661F NORTHWESTERN iawn eds UNIVERSITY one 2 foc 2500 To: — Antonitsa Viahoulis From: Don E. Workman © \¥* Executive Director, Office for the Protection of Research Subjects Ann K. Adams ®¥8\= Associate Vice President for Research Integrity Date: September 18, 2008 We are writing in response to the concems raised in your September 9, 2008 email to Dr. Don Workman. At the time of your email, Northwestern’s Office for Research Integrity had already initiated an investigation of similar allegations regarding Dr. McCarthy's potential research use of the Myxo-ETlogix 5100 ring. That investigation is now complete. On August 28. 2007, the device manufacturer, Edwards Lifesciences, confirmed by email that the Myxo-ETlogix 5100 ring was a minor modification to a preexisting, FDA cleared ing and as such was not an investigational device. In a separate email dated September 10, 2007, Edwards Lifesciences stated that the Myxo-ETlogix 5100 ring has been marketed in the United States since March 2006. The relevant emails are attached. Furthermore, we have reviewed the research records from your participation in the Atrial Fibrillation Database and they indicate that you received the Myxo-ETlogix 5100 ring during your operation on April 26, 2006. As the company has confirmed that the device was commercially available at that time and was not investigational in nature, the implantation of this device during your surgery was not research and did not require IRB approval Finally, Northwestemn’s records indicate that you authorized the release of your clinical records for research purposes. (See attached consent form.) This research was published by Dr. McCarthy in The Journal of Thoracic and Cardiovascular Surgery in 2008. We appreciate your bringing these issues to Northwestern University and hope this, information addresses your concerns.From: Susan Katz [mailto:Susan_Katz@edwaras.com) ‘Sent: Tuesday, August 28, 2007 4:03 PM To: Susan Katz; McCarthy, Patrick M.D. ‘Subject: RE: ear Dr. McCarthy: In response to your question The model $100 MeCarthy Myxo ETiogix Annulopiasty Ring is not an investigational device, According to the FDA guidance document dated January 10, 1997, Deciding When to Submit o 510(k) for o Change to an Existing Device, model 5100 is a miner modification of model 4200, GeoForm Annuloplasty Ring, cleared under KO32250. he applicable 510)k) number for mode! 5100 is KO22250. Let me know if this sufficiently answers your question? Regards, SusanFrom: Susan Katz {mallto:Susan_Katz@edwards.com) ‘Sent: Monday, September 10, 2007 11:11 AM To: Lynch, Julia (Ce: Susan Katz ‘Subject: RE: Model 5100 McCarthy Myxo Dear Julia It appears you are looking for information about authority to market the product. It has been marketed in the US since March 206 pursuant to the FDA's Siék clearance process. That process does not involve issuance of documentation by the FDA. Please let me know if you have further questions. Regards, Susan Katz Director of Marketing, Mitrat Eéwards Lifesciences (949) 250-2891Goos/017 Het Vahouls, Antony des NORTHWESTERN UNIVERSITY z ) Departments of Surgery and Medicine Division of Cardiothoracic Surgery and Cardiology #3. & CONSENT FORM Project Title: Early and Late Outcomes Following Surgical Intervention for Atrial Fibritlation Database Principal Investigator: Patrick McCarthy, M.D. Co-Investigator(s): Alan Kadish, MD; Edwin McGee, MD; Thomas Gleasoo, MD; Introduction/Purpose ‘You are being asked to participate in the Barly and Late Outcomes Following Surgical Intervention for Atrial Fibrillation Database (Databasc) because you have been diagnosed with «trial fibrillstion that requires treatment, Atrial Fibrillation (AF) is « condition when an irregular heartbeat is present because the upper chambers (atria) of the heart ere not contracting normally, but are instead quivering, "The purpose of this coasent is to allow researchers to review and compare medical information including symptoms, treatments and complications that people undergoing procedures for atrial brillation have. It will algo allow researchers to look at medical events that occur in people diagnosed ‘with and receiving treatment for atrial fibrillation, including results of any procedure you bave, In other words, this database will eventually be used to help physicians diagnose anid treat atrial fibrillation. Although the Database will contain your clinical information, it is not considered to be part of your clinical treatmnent, Procedures If you agree to participate in the Database, there will be no changes to your treatment for atrial Sibrillation. You will undergo surgery as assigned by your doctor. You will be asked to give consent for us to utilize all past and future information regerding care for your AF-related disease. This will include the consent for us to (i) review your hospital (Northwestem Memorial Hospital) and (2) ‘outpatient (Northwestem Memorial Faculty Foundation) medical records, and (3) have dizect contact ‘with you or your designated representative. In addition, you will be asked to sign a medical record release form allowing us to obtain Your records from any medical facility and/or physician office visit for treatment of your AF. In addition, after signing this form you may be asked to complete e quality of life questionnaize (a health-related questionnaire that will take you 5 to 10 mimutes to complete). You may be asked to complete a 2™ quality of life questionnaire 6 months after your surgery. The 6-month questionaire will be provided to you in one of 3 ways: 1) during a follow-up clinic visit 2) by phone 3) mail. The research staff will ask you which method you prefer to be contacted after signing this consent. If you prefer to complete the 6-menth questionnaire by mail you will be provided with a self-addressed, stamped envelope (o retum the completed questionnaire to the study personnel. This inforraation is being collected for research purposes. Page 1 of 3 Subject initials SX AF Outcosats, IRBY 1532-003, 9.12.0520/74/2008 08:32 FAX Boe sor7 Risks ) Your participation in the database does not involve any physical risk to you other than the possibility of lose of your privacy. Benefits ‘You will not personally benefit from your participation in this database. Your participation may aid in the treatment of AP, which in tum may help others. Alternatives ‘You have the altemative to choose not to participate in the Atrial Fibrillation Database. Ifyou decide not to participate, the decision will not affect your care. ce tial ‘Your participation in this Database may result in a loss of privacy, since persons other then the investigator(s) might view your records. Unless required by law, only the study investigetor, members of the investigator's staff and the Northwestern University Institutiont] Review Board will have authority to review your records. They are required to maintain confidentiality regarding your identity. Results of this study may be used for teaching, research, publications or presentations at scientific meetings, If your individual results are discussed, we will use a study code number, rather tben your name or other identifying information, to protect your identity. Examplos of identifying information include medical record number, social security number and address. Records of your ongoing participation in this study will be kept confidential at tho Cardiovascular Clinical Trials Office of the Bluhm Cardiovascular Institute. Financial Informati ‘Your participation in the Database is at no cost to you. Atno time during your participation will any personal financial information be asked of you. ‘You will not be paid for participation in this database, Subjects’ Rights Your participation in this outcomes Database is voluntary and you are free to withdraw at any time by contacting Patrick McCarthy, M.D. at (312)-695-31 14, or writing to Patrick McCarthy, M.D., Chief, Division of Cardiothoracic Surgery, Galter Pavilion 10-105, 201 East Huron Strett, Chicago, IL. 60611-2908. If you change your mind and want to withdraw at any time after your information has been entered into the datsbase your data will be excluded from further studies. Participation or ‘withdrawal will not affect your present or future medical treatment. ‘The Office for the Protection of Research Subjects of Northwestem University, at telephone number G12) 503-9938, ean provide further information about your rights as a research subject and is where any research related injury should be reported, Purther information regarding this study may be obtained by contacting Dr. McCarthy, Principal Investigator of the study, st telephone number (312) 695-3114, For problems arising evenings or weekends, you may call the same number. , Page 2083 subjectnta AF Ostoomes, IRB# 1532-008 3.12959/44/2008 08:19 FAX ) Consent @oos/o17 Thave read this form and the research study hes been explained to me. I have been given the ‘opportunity to ask questions and ray questions have been answered, If I have additional questions, 1 have been told who to contact. | agree to participate in the research study deseribed above aud will receive a copy of this consent form. [will receive a copy of this consent form after J sign it. 06 Bate N\ Subject’s Natne (printed) Subject’s Name Signanre hrs Leese, Le Name (printed) of Person Obtaining Consent Signature of Person Obtaining Consent We AF Outcomes, IRD# 1537-003 Page 3 0f3 912-05 Northrestorn Univers Instit rally ing pitti Review Bosra APPHOM EXPIRATION So0B Subject intialny Dol