MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Catalog Number 29MECJ-502

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was noted that on (b)(6) 2024, a 29mm sjm masters series valve expanded cuff was chosen for a procedure.The valve was implanted.One minute after the implantation, a moderate valvular leak was noted.The valve was explanted and mitral valve replacement (mvr) was done with a new 29mm sjm masters series valve expanded cuff intra-procedurally, while the patient was still on bypass.The patient remained hemodynamically stable throughout the procedure.There was no delay in the procedure.The patient was reported stable.

• Brand Name: MASTERS SERIES VALVE EXPANDED 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: 19015678
• MDR Text Key: 339129236
• Report Number: 2135147-2024-01465
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067045256
• UDI-Public: (01)05415067045256(17)280127(10)C00008223
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 04/01/2024

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: 29MECJ-502
• Device Lot Number: C00008223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2023
• 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