BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3894500 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03607
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE CRIMPED STENT. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. 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. A VISUAL AND TACTILE EXAMINATION FOUND AN ACUTE KINK ON THE HYPOTUBE SHAFT 345MM FROM THE STRAIN RELIEF. ON MICROSCOPIC EXAMINATION OF THIS ¿KINK¿ IT CAN BE DETERMINED THAT THE WALL OF THE HYPOTUBE SHAFT HAS BROKEN AND THEREFORE THE HYPOTUBE IS CONSIDERED BROKEN AT THIS LOCATION. THE HYPOTUBE ALSO HAS A KINK 260MM PROXIMAL FROM THE MID-SHAFT BOND. 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 PROFILE. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND SHAFT KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING THE ADVANCEMENT OF A NON-BSC GUIDEWIRE AND A NON-BSC GUIDE CATHETER, THE LESION WAS PRE-DILATED WITH 1.5X10MM AND 2X12MM UNSPECIFIED CATHETER BALLOONS AT 8-10 ATMOSPHERES FOR 15 SECONDS. A 3.00X16MM PROMUS ELEMENT ¿ STENT WAS SELECTED TO TREAT THE LESION BUT FAILED TO CROSS THE LESION. DURING MANIPULATION, IT WAS NOTICED THAT THE SHAFT GOT KINKED. THE PHYSICIAN WITHDREW THE DEVICE AND DEPLOYED ANOTHER 3X12MM PROMUS ELEMENT STENT AT 10 ATMOSPHERES FOR 20 SECONDS AND POST DILATED WITH A 3X8MM NC QUANTUM APEX CATHETER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371232 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 16210620

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GUIDEWIRE: BMW| GUIDE CATHETER: 6 FR- EBU