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

Catalog Number	29MECJ-502
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Explant due to perivalvular leak was reported.The investigation found that both leaflets were intact and opened and closed completely without difficulty.No material was seen within the pivot recesses or on the surfaces of the mechanical leaflets.The sewing cuff was intact.No inflammation.Hydrodynamic testing to evaluate valve function.Data and video of valve function, along with open & closed images, were obtained to evaluate hydrodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received the cause of the reported incident could not conclusively be determined.
Event or Problem 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 around the valve.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
• 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: 19015678
• Report Number: 2135147-2024-01465
• Device Sequence Number: 12757731
• Product Code: LWQ
• UDI-Device Identifier: 05415067045256
• UDI-Public: (01)05415067045256(17)280127(10)C00008223
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: C00008223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• 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