BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3160044 · Received June 10, 2013

    Report

    Report Number
    2134265-2013-03801
    Event Type
    Death
    Date Received
    June 10, 2013
    Date of Event
    February 27, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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: 2134265-2013-03800. (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENTS' QUALIFYING CONDITION WAS UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIA) WITH SILENT ISCHEMIA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION IN (B)(6) 2013. THE 99% STENOSED, 40MM IN LENGTH TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND THE PLACEMENT OF 2.75 X 38MM AND 3.00 X 12MM STUDY STENTS AND POST DILATATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER ON ASPIRIN AND CLOPIDOGREL. AT 51 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO CARDIAC REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260421 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312300 15059097

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death