BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3881862 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03768
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. STENT STRUTS THROUGHOUT THE ENTIRE DISTAL PORTION OF THE STENT WERE DEFORMED, STRETCHED AND LIFTED UPWARDS FROM THE STENT PROFILE. IT WAS NOTED THAT THE ENTIRE STENT MOVED 16MM DISTALLY ON THE BALLOON. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOONS PROXIMAL CONE PROFILE WAS REVIEWED AND NO ISSUES WERE NOTED. THE PROXIMAL BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. IT WAS NOT POSSIBLE TO EXAMINE THE DISTAL CONE OF THE BALLOON AS THE STENT HAD MOVED OUT OVER THE DISTAL PORTION. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT POLYMER EXTRUSION. 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 DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING DEPLOYMENT OF A 2.75X24 MM PROMUS ELEMENT ¿ DRUG ELUTING STENT AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, A 2.25X24MM PROMUS ELEMENT ¿ STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION IN THE LCX. WHILE DELIVERING THE STENT TO THE PROXIMAL PART OF THE LCX ARTERY THE STENT SEPARATED FROM THE BALLOON OF THE DELIVERY CATHETER. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25X24MM PROMUS ELEMENT ¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357493 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 16016091

    Patients

    Seq Age Sex Outcome Treatment
    1