BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3070817 · Received April 22, 2013

    Report

    Report Number
    2134265-2013-02434
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: INITIAL VISUAL EXAMINATION OF THE DEVICE FOUND SEVERE STENT STRUT DAMAGE. THE ENTIRE LENGTH OF THE STENT WAS STRETCHED AND WAS FOUND TO BE MOVING FREELY ON THE BALLOON. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO FURTHER DAMAGE WAS NOTED WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT FAILED TO CROSS THE LESION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED, DE NOVO 2.5X12MM LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATION WITH A 2.0X15MM MAVERICK BALLOON, THE 2.5X12MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THAT THE STENT WAS DAMAGED AND MOVED ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171271 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412250 15656897

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR