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

Model Number	21ATJ-503
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2002, a 21mm masters series heart valve with teflon cuff was successfully implanted in a patient's aortic valve.In (b)(6) 2023, the patient had a medical examination and the patient displayed symptoms of aortic stenosis: shortness of breath/dyspnea on exertion.An echocardiogram (echo) was performed, and mild-moderate aortic stenosis was confirmed.In may, the aortic stenosis progressed, and it was decided that valve replacement was necessary.On (b)(6) 2023, the device was explanted and a 19mm epic valve was implanted.Pannus was seen circumferentially on the inflow side of the masters valve, which indicated that the valve was not completely opening.The patient was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
An event of stenosis 21 years after the masters valve was implanted resulting in explant of the valve was reported.The valve was received for examination and no pannus or tissue was noted on the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that there was no change in appearance noted on the valve at explant and that the problem was not with the valve.The reported pannus on the inflow side of the valve could have contributed to the stenosis and incomplete coaptation reported.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART VALVE WITH TEFLON 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: 17144562
• Report Number: 2135147-2023-02622
• Device Sequence Number: 5577600
• Product Code: LWQ
• UDI-Device Identifier: 05414734028578
• UDI-Public: 05414734028578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2023
• 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): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21ATJ-503
• Device Catalogue Number: 21ATJ-503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG