MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number	505DA20
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 2 days following the implant of this mechanical valve, the patient died.The cause of death was not received.There was no evidence to suggest that the valve or its function contributed to the patient¿s death.It is unknown whether an autopsy was performed.It was reported the aortic and mitral valves were replaced following the explant of a transcatheter aortic valve (tav) which was explanted due to stenosis after three years implant duration.No further information was received.

• Brand Name: AORTIC AP
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9985473
• Report Number: 3008592544-2020-00030
• Device Sequence Number: 16667290
• Product Code: LWQ
• UDI-Device Identifier: 00643169335011
• UDI-Public: 00643169335011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 08/15/2021
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/22/2020
• 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: 63 YR