MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AORTIC FLEX; HEART-VALVE, MECHANICAL

Model Number	500FA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
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 44 days post implant of this 21mm aortic mechanical valve, it was explanted and replaced with a 27mm non-medtronic bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported.

• Brand Name: AORTIC FLEX
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 10662931
• Report Number: 3008592544-2020-00052
• Device Sequence Number: 19801105
• Product Code: LWQ
• UDI-Device Identifier: 00643169335097
• UDI-Public: 00643169335097
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 10/29/2024
• Device Model Number: 500FA21
• Device Catalogue Number: 500FA21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/12/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR