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

Model Number	505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/02/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that during the implant procedure of this mechanical valve.The cause of death was reported to possibly be because the patient never received retrograde cardioplegia; the patient only received antegrade cardioplegia.Therefore, the patient had a "stone heart" when trying to get him off pump.With a 20% ejection fraction (ef), antegrade perfusion alone proved to be insufficient, and the patient's heart did not regain beating after coming off of cardiopulmonary bypass.There were no allegations against the valve or its function.It is not known whether an autopsy was performed.
Additional Manufacturer Narrative
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.

• Brand Name: AORTIC AP
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6215433
• Report Number: 3008592544-2016-00067
• Device Sequence Number: 13545122
• Product Code: LWQ
• UDI-Device Identifier: 00643169334991
• UDI-Public: 00643169334991
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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: 09/12/2019
• Device Model Number: 505
• Device Catalogue Number: 505DA24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 09/28/2017
• 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: 55 YR
• Patient Weight: 145