BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3043132 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02631
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    October 3, 2012
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. 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

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL JAILING AND MYOCARDIAL INFARCTION (MI) OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS FOUND TO HAVE SEVERE LEFT ANTERIOR DESCENDING ARTERY DISEASE. THE PATIENT WAS THEN REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.5 X 20 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. FOLLOWING STENT DEPLOYMENT, THE FIRST SEPTAL PERFORATOR VESSEL WAS JAILED AND THE PATIENT EXPERIENCED CHEST PAIN. ELECTROCARDIOGRAM (ECG) SHOWED AN ST DEPRESSION. PRIOR TO DISCHARGE, LABORATORY INVESTIGATIONS REVEALED ELEVATED CARDIAC ENZYMES QUALIFYING AS A MYOCARDIAL INFARCTION. AN ECG WAS PERFORMED WHICH SHOWED NO ACUTE CHANGES, LOCATION OF MI WAS NOT IDENTIFIABLE. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON ASPIRIN AND CLOPIDOGREL ONE DAY POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146316 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420350 15268829

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention