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

Model Number 21ATJ-503

Device Problems Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816)

Event Date 05/19/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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
• 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: 17144562
• MDR Text Key: 317336761
• Report Number: 2135147-2023-02622
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734028578
• UDI-Public: 05414734028578
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG