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

Catalog Number 19AGN-751

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2024, a 19mm sjm regent heart valve was chosen for a aortic valve replacement (avr) procedure.During preparation, there was nothing wrong with the valve.The valve was implanted in the patient.After the procedure, once the valve was implanted it was found that the valve leaflet couldn't move.The physician removed the valve and a new 19mm non-abbott valve was implanted intra-procedurally, while the patient was still on bypass.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.

Manufacturer Narrative

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

• 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: 19146344
• MDR Text Key: 341125644
• Report Number: 2135147-2024-01778
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: (01)05414734005869(17)251105(10)7731655
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/19/2024

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 Catalogue Number: 19AGN-751
• Device Lot Number: 7731655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2020
• 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: 40 YR
• Patient Sex: Female