MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	T505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/17/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been received for analysis.Without the return of the product, a definitive conclusion cannot be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from the patient's family member that an unknown duration post-implant of this device, the patient's "valve failed" and the patient died.The cause of death is unknown.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received from the physician indicated that the patient's death was unrelated to the patient's medtronic device.No other adverse patient effects were reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6553343
• Report Number: 2025587-2017-00761
• Device Sequence Number: 16283108
• Product Code: LWR
• UDI-Device Identifier: 00643169534094
• UDI-Public: 00643169534094
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2017
• Device Model Number: T505
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided; 05/16/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/23/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR