MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 27AGN-751

Device Problem Material Separation (1562)

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

Event Date 01/02/2023

Event Type  malfunction  

Manufacturer Narrative

An event of the sewing cuff fabric loosened from the cuff was reported.Information from field indicated that broken sutures were identified after putting two sutures into the cuff of the valve.The valve was returned to abbott and the investigation found sewing cuff fabric was loose and appeared to be separated.The device history record along with incoming records and manufacturing controls for suture were also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications at the time of commercialization, including visual inspection of the valve and confirmation that the sutures are intact.The review determined the process was performed and completed in accordance with abbott specifications and procedures.This was inclusive of a review of the sewing cuff was complete and inspected for loose or broken sutures.The cause of reported event could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2023 a 27mm regent aortic mhv, was selected for an implant.During the procedure, as the implanting physician put 2 sutures into the cuff of the valve, the sewing cuff fabric loosened from the cuff and the device was never parachuted down in the annulus.The device was never implanted in the patient.The qa seal on the product box was intact and the product box containing the device did not appeared damaged in any way or was damaged due to handling during preparation.Device was replaced with a 27mm regent aortic mhv device that was successfully implanted.The rest of the surgery went well without any adverse events.No patient consequences were reported.No additional information was provided.

• Brand Name: REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16518631
• MDR Text Key: 311041028
• Report Number: 2135147-2023-01104
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006392
• UDI-Public: 05414734006392
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P810002
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27AGN-751
• Device Catalogue Number: 27AGN-751
• Device Lot Number: C00001105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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