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

Model Number 40025

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was discolored showing evidence of blood contact.All leaflets were flexible, intact, and in the closed position.No leaflet damage was observed.All commissures were intact and no commissure damage was noted.The valve sewing ring was measure and found acceptable within the 25mm size valve specification.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.This valve was re-assessed for size confirmation and confirmed to meet requirements.Based on the information available, the root cause of this complaint cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 25mm bioprosthetic valve, the sutures were set into the sewing ring and valve pulled down, but the valve could not pass through the sinotubular junction (stj).The physician re-sized and confirmed both ends of the sizer read 25mm.The 25mm was retrieved.A 23mm bioprosthetic valve of the same model was implanted.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11017408
• MDR Text Key: 223615306
• Report Number: 2025587-2020-03824
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: 40025
• Device Catalogue Number: 40025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 68