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

Model Number 1000-21

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted; therefore, no product analysis can be performed.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 Description

Medtronic received information that 9 years and 5 months post implant of this 21mm bioprosthetic aortic valve, a transcatheter valve was implanted valve-in-valve.The reason for intervention was reported as severe aortic stenosis.No additional adverse patient effects were reported.

• Brand Name: THV 1000-21 3F AORTIC BIO 21MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11065059
• MDR Text Key: 223392881
• Report Number: 2025587-2020-03932
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00613994868220
• UDI-Public: 00613994868220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000-21
• Device Catalogue Number: 1000-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR