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

Model Number 1000-27

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); No Information (3190)

Event Date 10/06/2020

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 11 years and 10 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.

Manufacturer Narrative

Medtronic received additional information that the aortic valve was replaced due to moderate regurgitation.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: THV 1000-27 3F AORTIC BIO 27MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10705463
• MDR Text Key: 212113465
• Report Number: 2025587-2020-03165
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000-27
• Device Catalogue Number: 1000-27
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR