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

Model Number	27MJ-501
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
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) 2020 a sjm master series mechanical heart valve was implanted in the patients mitral position.On (b)(6) 2020 the sjm master's series mechanical heart valve was explanted due to thrombus.A 27 mm epic stented porcine heart valve w/ flexfit system was thought to be implanted as a replacement.Warfarin has been prescribed to the patient, but the internal medicine department at the hospital kept the patient's prothrombin time-international normalized ratio(pt-inr) rather low at 1.49 for the dialysis patient.The patient's fibrinogen was 690mg/dl and the plt(platelet) was 500,000¿l; the patient seemed to have had thrombogenesis tendency which might have been due to cholecystitis inflammation.The patient is stable.
Additional Manufacturer Narrative
Explant was reported due to thrombus after about 2 months of device implant.The investigation found that there was limited mobility of one mechanical leaflet and the other was immobile.There was thrombus present at both pivot recesses, which had areas of calcification.Acute and chromic inflammation was present on the sewing cuff.Gram stains were negative for organisms.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 the patient seemed to have a tendency for thrombogenesis, possibly due to cholecysitis inflammation.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• 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: 10195128
• Report Number: 2648612-2020-00070
• Device Sequence Number: 2924644
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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: 2020
• 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): 08/05/2020

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: 05/31/2020
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 5109373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: 50 YR