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

Catalog Number 23AGFN-756

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 11/04/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2023, a 23mm regent aortic mechanical heart valve with flex cuff was chosen for implant.After the valve was successfully implanted, the valve leaflets could not open or close.During the attempt to adjust the opening and closing direction of the valve, using surgical forceps, a small piece of the valve orifice was noted to crack.The valve was removed and a replacement 23mm regent aortic mechanical heart valve with flex cuff was successfully implanted.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

An event of the leaflets not moving once the valve was implanted and the valve chipping during an attempt to rotate the valve was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The investigation confirmed that both leaflets moved with ease under non-physiological conditions.The pivot guard was chipped.Information from the field indicated the orifice chipped while they were attempting to rotate the valve, which could have caused the damage noted.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• 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: 18240923
• MDR Text Key: 329776921
• Report Number: 2135147-2023-05270
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00006966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG