MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number	25MTJ-503
Medical Device Problem Codes	Backflow (1064); Biocompatibility (2886)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019 a sjm masters series heart valve w/teflon cuff was implanted in the diabetic and dialysis patient, a supra-annular position using non-everting mattress suture technique with the pledgets on the outflow side.An abbott sizer (model#: 905) was used in the surgery.It was confirmed by the x-ray fluoroscopy during a follow-up that one of the leaflets on the valve was not moving, and on (b)(6) 2020, a re-do avr was performed.The 25mm sjm master series heart valve w/ teflon cuff was explanted and replaced with a 23mm sjm master series heart valve w/teflon cuff (serial # (b)(4)).Upon explant of the valve, thrombus was confirmed to be adhered at the pivot guard hinge, impeding the leaflet mobility.It was reported that international normalized ratio of prothrombin time (inr) was maintained at 2.1 before the re-do avr, and the patient has had been administered anticoagulants.The pathological examination concluded that the issue was due to thrombus, but the surgeon requested pannus formation on the valve, also.
Additional Manufacturer Narrative
The reported thrombus in the recessed pivot areas, impeding leaflet mobility, was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root cause of the thrombus could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10201349
• Report Number: 2648612-2020-00071
• Device Sequence Number: 11416295
• Product Code: LWQ
• UDI-Device Identifier: 05414734053617
• UDI-Public: 05414734053617
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: 25MTJ-503
• Device Catalogue Number: 25MTJ-503
• Device Lot Number: 6380357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR