BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3061201 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02369
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVIC IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE >90% STENOSED TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX ARTERY. A 2.50X20MM PROMUS ELEMENT PLUS CORONARY DRUG ELUTING STENT WAS INTENDED TO BE USED FOR THE TREATMENT. WHEN IT WAS ABOUT TO BE INSERTED INTO THE PATIENT, IT GOT CAUGHT ON THE OPENING OF THE TUOHY STILL OUTSIDE THE PATIENT'S BODY. THE STRUTS APPEARED TO HAVE BENT AND LIFTED OFF FROM THE STENT DELIVERY SYSTEM SPECIFICALLY ON THE DISTAL END. THE DEVICE WAS THEN COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163905 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420250 15348299

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR