BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4185067 · Received October 20, 2014

    Report

    Report Number
    2134265-2014-06541
    Event Type
    Death
    Date Received
    October 20, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION DEVICE. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-06539 AND 2134265-2014-06540: IT WAS REPORTED THAT A DEATH OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN CANULATED THE 90% STENOSED DE NOVO LESION LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY WITH A 7F MACH 1 FL 3.5 AND THEN PARKED THE WIRE. AFTER PRE DILATATION, THE PHYSICIAN WAS ATTEMPTING TO PLACE THE STENT, BUT THE GUIDE CATHETER DISSECTED THE LEFT MAIN ARTERY. THE PHYSICIAN DEPLOYED THE 3.5X20MM PROMUS ELEMENT ¿ STENT TO COVER THE DISSECTION. BECAUSE THE DISSECTION FLAP EXTENDED UP TO THE OSTIAL PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), THE PHYSICIAN DEPLOYED THE SECOND STENT WHICH WAS A 3X24 PROMUS ELEMENT ¿ TO COVER THE EXTENDED DISSECTION FLAP. POST PROCEDURE, THE PATIENT¿S LEFT VENTRICLE EJECTION FRACTURE CAME DOWN TO 20% WHICH LED TO CARDIAC ARREST. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND DIED 2 HOURS LATER DUE TO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665195 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324300 16798535

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death