BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3833871 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-03004
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    December 12, 2013
    Report Date
    May 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT HAD DETACHED FROM THE BALLOON AND WAS RETURNED FOR ANALYSIS WITH THE DEVICE. THE STENT PROTECTOR WAS NOT RETURNED FOR ANALYSIS. THE ENTIRE STENT WAS DAMAGED WITH THE STENT STRUTS STRETCHED AND DISTORTED. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. CRIMP MARKINGS WERE EVIDENT ON THE WALL OF THE BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.50X16MM PROMUS ELEMENT¿ PLUS STENT DELIVERY SYSTEM WAS SELECTED TO TREAT THE LESION. DURING THE ATTEMPT TO DEPLOY THE STENT, THE BALLOON WAS DETACHED WITH DAMAGE, PREVENTING ITS USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.50X16MM PROMUS ELEMENT¿ PLUS STENT DELIVERY SYSTEM WAS SELECTED TO TREAT THE LESION. DURING THE ATTEMPT TO DEPLOY THE STENT, THE BALLOON WAS DETACHED WITH DAMAGE, PREVENTING ITS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310925 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416350 0016122733

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR