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

Model Number 40027

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: 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 the replica end of the sizing tool for this 27mm aortic bioprosthetic valve were used during the sizing process, the surgeon chose to attempt the 27mm valve for a greater effective orifice area (eoa) and a body surface area (bsa) chart was not used for valve sizing.It was reported that after pledget placement and suturing, the surgeon decided this 27mm bioprosthetic valve was too large, the valve was explanted and replaced with a 25mm valve of the same model.No additional adverse patient effects were reported.

• 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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13979737
• MDR Text Key: 289018341
• Report Number: 2025587-2022-00872
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: 40027
• Device Catalogue Number: 40027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2022
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention