BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 3022810 · Received March 22, 2013

    Report

    Report Number
    2648612-2013-00013
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO INC (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE VALVE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO EVIDENCE FOUND TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED LEAFLET BEING IMPEDED REMAINS UNK; HOWEVER, THE PT WAS NOTED TO HAVE UNDERGONE THROMBOLYSIS THERAPY.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE VALVE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO EVIDENCE FOUND TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED LEAFLET BEING IMPEDED REMAINS UNK; HOWEVER, THE PT WAS NOTED TO HAVE UNDERGONE THROMBOLYSIS THERAPY.

    Description of Event or Problem · 1

    THIS MECHANICAL VALVE WAS IMPLANTED DUE TO MITRAL STENOSIS. APPROXIMATELY ONE MONTH POSTOPERATIVELY, THE PT HAD AN INTRACEREBELLAR BLEED AND HAD BEEN ADVISED TEMPORARY CESSATION OF ANTICOAGULATION. ONE MONTH LATER, THE PT WAS READMITTED SINCE THE LEAFLETS OF THE VALVE WERE IMPEDED AND UNDERWENT THROMBOLYSIS WITH A HALF DOSE OF STREPTOKINASE AND HAD A GOOD RESULT. ANTICOAGULATION WAS CONTINUED AND THE PT WAS WELL UNTIL SHE PRESENTED TO THE HOSP WITH SYMPTOMS AND WAS FOUND TO HAVE A VALVE WITH ONLY ONE LEAFLET MOVING. THE VALVE WAS EXPLANTED AND WAS REPLACED WITH AN SJM 27 MM TISSUE VALVE. THE PT WAS REPORTED TO BE STABLE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119707 SJM MECHANICAL HEART VALVE STANDARD HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO INC (CS) 27M-101

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R