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

Model Number	25MECJ-502
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a sjm masters series valve with expanded cuff was successfully implanted in a patient.On (b)(6) 2022, the patient returned for a routine follow up and was discovered to have mitral valve stenosis.The decision was made to explant the sjm masters series valve and replace it with a non-abbott device.The patient was stable at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a sjm masters series valve with expanded cuff was successfully implanted.On 10 august 2022, the patient returned for a routine follow up and was discovered to have mitral valve stenosis.A transesophageal echocardiogram (tee) was done, and it was observed that the valve was stiff and one of the leaflets was stuck.The decision was made to explant the sjm masters series valve and replace it with a 25mm non-abbott device.The patient was stable and discharged at the time of report.
Additional Manufacturer Narrative
Explant due to the valve not being coapting properly and one of the leaflets being stuck was reported.The investigation found that both leaflets were intact and opened and closed completely but moved with difficulty.No material was seen within the pivot recesses or on the surfaces of the mechanical leaflets.The sewing cuff was intact.There was a patchy fibrous pannus formation on the sewing cuff which did not appear to impinge upon the mechanical components.No inflammation.Sections of material removed from the sewing cuff consisted of fibrous tissue consistent with pannus.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The limited leaflet mobility could lead to a number of potential issues with valve functionality.

• 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: 15374490
• Report Number: 2135147-2022-01044
• Device Sequence Number: 5820997
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• 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: 2022
• Device Explanted Year: 2022
• 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): 12/27/2022

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: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: 8230975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 12/25/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female