BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MASTERS SERIES VALVE EXPANDED CUFF

    MDR report key: 1730094 · Received June 18, 2010

    Report

    Report Number
    2648612-2010-00036
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    February 13, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION INDICATED THERE WAS NO EVIDENCE OF MATERIAL DEFECT IN THE CARBON COATING THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE FRACTURED LEAFLET AND ORIFICE DAMAGE. RATHER, THE DAMAGE WAS APPARENTLY CAUSED BY SOME EXTERNAL FORCE APPLIED TO THE LEAFLET WHICH OVERSTRESSED THE CARBON MATERIAL AND RESULTED IN THE DAMAGE. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE FRACTURED LEAFLET AND ORIFICE DAMAGE WERE DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY THE REVIEW OF THE DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE FRACTURED LEAFLET DURING IMPLANTATION REMAINS UNK.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING DOUBLE VALVE REPLACEMENT AND CABG AND HAD EXTENSIVE AORTIC CALCIFICATION. SIGNIFICANT ARTERIAL OOZING WAS EXPERIENCED. IT WAS REPORTED THE SURGEON PARACHUTED THE VALVE INTO THE PATIENT'S AORTIC ANNULUS AND AS THE SURGEON SEATED THE VALVE, ONE OF THE LEAFLETS FRACTURED. ALL OF THE PIECES WERE RETRIEVED AND A LARGER 21 MM REGENT VALVE WAS IMPLANTED. THE PATIENT EXPERIENCED A POSTERIOR ATRIOVENTRICULAR DISRUPTION INTRAOPERATIVELY WITH MASSIVE BLEEDING AND EXPIRED FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES VALVE EXPANDED CUFF ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 19AECJ-502

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| R