BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONIC VALVE

    MDR report key: 306844 · Received November 30, 2000

    Report

    Report Number
    3071347-2000-00001
    Event Type
    Death
    Date Received
    November 30, 2000
    Date of Event
    October 2, 2000
    Report Date
    November 29, 2000
    Manufacturer
    PUGET SOUND BLOOD CENTER NORTHWEST TISSUE CTR
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY IN 2000 FOR CLOSURE OF BLALOCK SHUNT, PATCH ENLARGEMENT OF THE RIGHT PULMONARY ARTERY, PATCH CLOSURE OF VENTRICULAR SEPTAL DEFECT, COMPOSITE CONDUIT 21 MM HOMOGRAFT RIGHT VENTRILE TO PULMONARY ARTERY, DACRON/HOMOGRAFT. DURING THIS OPERATION, PT DEVELOPED COAGULOPATHY AND HIGH RIGHT-SIDED PRESSURES. AFTER BYPASS WAS DISCONTINUED THE HEMODYNAMICS WERE STABLE. THEN BOTH THE PT'S TISSUE AND THE HOMOGRAFT BLED FROM SEVERAL POINTS. PT WAS RETURNED TO BYPASS SEVERAL TIMES AND HEMOSTASIS, WITH THE EXCEPTION OF COAGULOPATHY, WAS ACHIEVED. THE PT WAS RETURNED TO ICU. IN 2000 PT DEVELOPED EXTENSIVE COAGULOPATHY PLUS HAD MULTIPLE AREAS OF BLEEDING FROM SURGICAL SITES. PT WAS BROUGHT BACK INTO THE OPERATING ROOM AND HAD MULTIPLE BLEEDING SITES CAUTERIZED. MANY ADD'L SUTURES WERE NECESSARY TO CONTROL THE BLEEDING. PT WAS RETURNED TO THE ICU IN STABLE CONDITION. THE PT EXPIRED SOMETIME DURING THE POSTOPERATIVE PERIOD. THE CO IS AWAITING THE DISCHARGE SUMMARY. BECAUSE OF THE HIGH SYSTEMIC PRESSURES, THE SURGEON REMARKED THAT PERHAPS THE SURGEON SHOULD HAVE USED AN AORTIC ALLOGRAFT. NEITHER THE ALLOGRAFT TISSUE NOR THE PT'S OWN TISSUE HELD THE SUTURES WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONIC VALVE ALLOGRAFT HEART VALVE LMO PUGET SOUND BLOOD CENTER NORTHWEST TISSUE CTR VPV60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death