MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION THV 1000-27 3F AORTIC BIO 27MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	1000-27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); No Information (3190)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 6 years and 6 months post implant of this aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that the aortic bioprosthetic valve was replaced valve-in-valve due to severe insufficiency.If information is provided in the future, a supplemental report will be issued.

• Brand Name: THV 1000-27 3F AORTIC BIO 27MM
• 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: 8416451
• Report Number: 2025587-2019-00911
• Device Sequence Number: 11088678
• Product Code: LWR
• UDI-Device Identifier: 00613994961594
• UDI-Public: 00613994961594
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P060025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 01/19/2019
• Device Model Number: 1000-27
• Device Catalogue Number: 1000-27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 05/20/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/14/2019; 05/21/2019
• 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: 61 YR
• Patient Weight: 105