BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6109058 · Received November 17, 2016

    Report

    Report Number
    2134265-2016-10106
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 21, 2016
    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 A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    SAME CASE AS MDR ID: 2134265-2016-10107 AND 2134265-2016-10108. IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH ANTERIOR WALL MYOCARDIAL INFARCTION WITH LEFT VENTRICULAR DYSFUNCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE PATIENT WAS IMMEDIATELY TAKEN TO THE CATHETER LABORATORY. DURING THE PROCEDURE, IT WAS FOUND THAT THE SYSTEM WAS LEFT DOMINANT AND THE CULPRIT VESSEL WAS LAD. THE DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN INITIALLY IMPLANTED A 2.25X28MM PROMUS ELEMENT " DRUG-ELUTING STENT IN THE DISTAL SEGMENT OF LAD. THE PHYSICIAN THEN ADVANCED A 2.75X38MM PROMUS ELEMENT " LONG AND IMPLANTED IT IN THE MID SEGMENT OF LAD OVERLAPPING THE DISTAL SEGMENT OF LAD. THE PHYSICIAN DECIDED TO IMPLANT ONE MORE STENT FROM LEFT MAIN (LM) TO LAD. A 32X3.50MM PROMUS PREMIER" DRUG-ELUTING STENT WAS ADVANCED AND IMPLANTED IT FROM LM TO LAD, OVERLAPPING THE MID SEGMENT OF THE 2.75X38MM PROMUS ELEMENT " LONG STENT. IT WAS TOLD THAT DURING THE IMPLANTATION OF THE PROMUS PREMIER" FROM LM TO LAD, THE LEFT CIRCUMFLEX (LCX) GOT JAILED AND THEN NO FLOW HAPPENED. SINCE LCX WAS THE ONLY REMAINING VESSEL IN THE LEFT DOMINANT SYSTEM, PATIENT CRASHED AND ALL THE RESCUE ATTEMPTS WERE PERFORMED BY THE PHYSICIAN AND THE CATHETER LABORATORY STAFF. THE PHYSICIAN WIRED THE LCX AND TRIED TO RE-ESTABLISH THE BLOOD FLOW IN LCX, HOWEVER, THE PATIENT DID NOT RECOVER AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759481 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328220 18819503

    Patients

    Seq Age Sex Outcome Treatment
    1 Death