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

Model Number 40027

Device Problems Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during the implant of this 27mm aortic bioprosthetic valve, it was reported that there was poor coaptation of the valve leaflets.It was stated that severe aortic insufficiency (ai) was present for about 5-10 minutes post implant after having seated the valve in and then closed the incision.It was further stated that the patient was put on a pump and the issue resolved instantly with the leaflets returning back to normal and no central jet observed.Central jet appeared then resolved on its own.It was noted that the device had been inspected prior to use.It was mentioned that the patient was discharged and is doing well.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: 19031926
• MDR Text Key: 339235479
• Report Number: 2025587-2024-02065
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983212
• UDI-Public: 00643169983212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40027
• Device Catalogue Number: 40027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Date Device Manufactured: 08/24/2023
• 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): Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male