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

Model Number	27AGN-751
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2135147-2023-01104
• Device Sequence Number: 14278227
• Product Code: LWQ
• UDI-Device Identifier: 05414734006392
• UDI-Public: 05414734006392
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown