BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 1185004 · Received October 2, 2008

    Report

    Report Number
    2522007-2008-00007
    Event Type
    Death
    Date Received
    October 2, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 16, 2008
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT RETURNED FROM CUSTOMER. PRODUCT HAS NOT BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    COMPLAINT REPORT STATES, "INITIALLY REMOVAL WAS ATTEMPTED USING 10.5F POLYPROPYLENE BYRD DILATORS/LIBERATOR LOCKING STYLET BUT AN 11F EVOLUTION WAS QUICKLY UTILIZED WHEN THE BYRD DILATORS FAILED TO PROGRESS ALONG THE LEAD. PROGRESS WAS SLOW BUT CONSTANT OVER THE ICD LEAD IN THE SVC AREA DUE TO QUITE SEVERE FIBROSIS IN THE VEIN. THE ICD AND ATRIAL LEADS WERE BOUND TOGETHER IN THIS REGION BUT SEPARATED UNTIL THE TIP OF THE EVOLUTION REACHED THE MID TO LOWER ATRIUM. THE PROXIMAL SHOCKING COIL WAS PASSED SUCCESSFULLY AT THIS POINT BUT THEN PROGRESS SLOWED AS THOUGH THERE WAS A VERY SEVERE AREA OF FIBROSIS AS EVOLUTION PASSED TOWARDS THE DISTAL SHOCKING COIL. THE LEAD AND EVOLUTION REMAINED CO-AXIALLY ALIGNED WITH NO APPARENT DEVIATION AWAY FROM WHAT WOULD BE CONSIDERED NORMAL "TRACKING" OVER THE LEAD. AFTER A SHORT PERIOD OF ROTATING EVOLUTION IN THIS AREA DR VERY QUICKLY RECOGNIZED THAT CARDIAC TAMPONADE HAD OCCURRED AND THE PT WAS IMMEDIATELY PLACED ON CARDIAC BYPASS TO ALLOW FOR INVESTIGATION OF THE PROBLEM. AT SURGERY, A SMALL TEAR OF THE ATRIAL WALL WAS IDENTIFIED AND REPAIRED SUCCESSFULLY, IT WAS COMMENTED THAT THE LEAD WAS ADHERENT TO THE ATRIAL WALL AND ALSO BOUND TO THE SECOND (ATRIAL) LEAD. PT EXPIRED NEXT DAY (2008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-11.0 N76798

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death