BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3102831 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03127
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6) OR OLDER. THIS IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT DAMAGE AND VESSEL DISSECTION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 20MM PROMUS ELEMENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION EVEN AFTER SEVERAL ATTEMPTS. AN ANTIDROMIC DISSECTION OCCURRED FROM THE LAD PROXIMAL TO THE LEFT MAIN CORONARY ARTERY (LMCA). THE LAD THEN HAD NO FLOW THUS THE PHYSICIAN REMOVED THE PROMUS ELEMENT SDS AND FOUND THAT THE STENT PROXIMAL EDGE HAD LIFTED. NON-BSC STENTS WERE IMPLANTED IN THE LMCA-LAD PROXIMAL TO TREAT THE DISSECTION. AFTER WHICH, THE LAD AND THE LEFT CIRCUMFLEX BECAME A NO FLOW. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) SYSTEM WAS PLACED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION IMPROVED. THEN PATIENT DIED ONE DAY AFTER THE PROCEDURE DUE TO BLEEDING FROM PCPS. THE PHYSICIAN FELT THE STENT WAS DAMAGED DUE TO A 90 DEGREE BEND IN THE CALCIFIED LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203213 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 14967418

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R