BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4190134 · Received October 21, 2014

    Report

    Report Number
    2134265-2014-06462
    Event Type
    Death
    Date Received
    October 21, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 26, 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 PRODUCT. THE 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

    IT WAS REPORTED THAT THROMBOSIS AND DEATH OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 82% STENOSED, 2.5X27MM, CONCENTRIC, DE NOVO LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED. A 2.50X28MM PROMUS ELEMENT ¿ STENT WAS IMPLANTED AND THE PATIENT WAS STABLE POST PROCEDURE. TWO DAYS LATER, THE PATIENT WAS DISCHARGED. THREE DAYS FOLLOWING DISCHARGE, THE PATIENT REPORTED TO THE HOSPITAL EMERGENCY ROOM WITH ACUTE CHEST PAIN. AN ANGIOGRAM REVEALED SUBACUTE THROMBOSIS (SAT). THE PHYSICIAN USED AN INTRA-AORTIC BALLOON PUMP (IABP) AND THROMBUS SUCTION DEVICES, WHICH THE PATIENT RESPONDED TO. HOWEVER, THE PATIENT WAS IN THE CORONARY CARE UNIT (CCU) FOR TWO DAYS THEN DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668601 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 16468876

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R