BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3883612 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03408
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.   (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE STENT WAS DAMAGED AND STRETCHED FROM THE MIDDLE OF THE STENT TO ITS PROXIMAL END. AS A RESULT OF THIS DAMAGE, THE STENT WAS STRETCHED 0.5 MM OVER THE PROXIMAL MARKERBAND; HOWEVER, THE STENT WAS STILL IN PLACE AT ITS DISTAL END. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT. THE RO MARKERBANDS WERE EXAMINED AND THERE WAS NO DAMAGE NOTED. THEIR PROFILES MET THE SPECIFICATION. THE TIP OF THE DEVICE WAS EXAMINED AND THERE WAS NO DAMAGE NOTED. THE PROFILE MET THE SPECIFICATION. THE BALLOON CONE 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. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS LIKELY TO HAVE BEEN CAUSED BY EXCESSIVE TENSILE FORCES BEING APPLIED TO THE DELIVERY SYSTEM. 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 STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 18MM IN LENGTH, 2.25MM IN DIAMETER, ECCENTRIC AND THE DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED BETWEEN A 45 AND 95 DEGREE BEND. A NON-BSC GUIDE WIRE AND A 3.5 NON-BSC GUIDE CATHETER WERE ADVANCED TO THE LESION. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER, LEAVING 70% RESIDUAL STENOSIS IN THE LESION. A 2.25X20MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION HOWEVER, RESISTANCE WAS ENCOUNTERED DURING ADVANCING. DURING WITHDRAWAL IT WAS NOTED THAT THE DEVICE BECAME HOOKED IN THE GUIDE CATHETER. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 18MM IN LENGTH, 2.25MM IN DIAMETER, ECCENTRIC AND THE DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED BETWEEN A 45 AND 95 DEGREE BEND. A NON-BSC GUIDE WIRE AND A 3.5 NON-BSC GUIDE CATHETER WERE ADVANCED TO THE LESION. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER, LEAVING 70% RESIDUAL STENOSIS IN THE LESION. A 2.25X20MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION HOWEVER, RESISTANCE WAS ENCOUNTERED DURING ADVANCING. DURING WITHDRAWAL IT WAS NOTED THAT THE DEVICE BECAME HOOKED IN THE GUIDE CATHETER. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359821 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420220 16201272

    Patients

    Seq Age Sex Outcome Treatment
    1 EBU 3.5 GUIDE CATHETER| BMW GUIDE WIRE