MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION THV 1000-21 3F AORTIC BIO 21MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	1000-21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product remains implanted; therefore, 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 3 years 11 months post implant of this 21mm bioprosthetic aortic valve, a 23mm transcatheter valve was implanted valve-in-valve.It was reported that the valve was severely stenotic, with an aortic valve area of 0.4cm².No additional adverse patient effects were reported. .

• Brand Name: THV 1000-21 3F AORTIC BIO 21MM
• 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: 9186840
• Report Number: 2025587-2019-03122
• Device Sequence Number: 14044001
• Product Code: LWR
• UDI-Device Identifier: 00613994868220
• UDI-Public: 00613994868220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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: 01/26/2016
• Device Model Number: 1000-21
• Device Catalogue Number: 1000-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: Required Intervention
• Patient Age: 57 YR