MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40025

Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190)

Patient Problems Intimal Dissection (1333); No Information (3190)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that immediately post implant of this 25mm aortic bioprosthetic valve, the valve was explanted and replaced with a 27mm bioprosthetic valve of a different model.The reason for replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that this patient's aortic valve was sized according to the instructions for use (ifu) for this product, and a 25mm valve was selected.Upon seating and partially anchoring the 25mm valve into place, the aorta showed signs of tension and possible tear.It was determined that the valve was too large for the patient's anatomy.Subsequently the valve was removed and replaced with a valve of a different size and model.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• 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: 9312524
• MDR Text Key: 166934559
• Report Number: 2025587-2019-03460
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983205
• UDI-Public: 00643169983205
• Combination Product (y/n): N
• PMA/PMN Number: P170006
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: 40025
• Device Catalogue Number: 40025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 95