BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3880731 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03397
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    August 14, 2013
    Report Date
    May 22, 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. DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. A STENT STRUT ON THE 16TH ROW FROM THE PROXIMAL EDGE WAS LIFTED UPWARDS FROM ITS PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE. THIS IS CONSISTENT WITH DIFFICULTY CROSSING A LESION. 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. 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 ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PROCEDURE WAS INDICATED DUE TO CHEST PAIN. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 23MM X 3.0MM, ECCENTRIC, DE NOVO, 90% STENOSED TARGET LESION CONTAINED A >45 AND <90 DEGREE BEND AND WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED USING 1.5 X 8MM AND 1.5 X 20MM BALLOON CATHETERS. FOLLOWING PRE-DILATATION, THE LESION HAD 60% STENOSIS AND A 3.00X38MM PROMUS ELEMENT LONG STENT DELIVERY SYSTEM WAS ADVANCED. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING INSERTION AND THE DEVICE FAILED TO CROSS THE LESION WITH A DURATION ATTEMPT OF 10 TO 15 MINUTES. ANOTHER ATTEMPT WAS MADE BUT STILL THE DEVICE WAS NOT ABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. POST PROCEDURE, THE PATIENT WAS ON HEPARIN AND CLOPIDOGREL AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357303 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 16179327

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDEWIRE: BMW