BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 3011488 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01505
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT WAS RETURNED DAMAGED ON THE DISTAL AND PROXIMAL END. THE STRUTS ON THE FIRST TWO ROWS ON THE DISTAL END OF THE STENT WERE RAISED UP. THERE WAS ONE STRUT MISALIGNED ON THE PROXIMAL END OF THE STENT. THE BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. THERE WAS NO EVIDENCE THAT THE STENT HAD MOVED ON THE BALLOON. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE AND STENT MOVED ON BALLOON OCCURRED. THE LESION WAS SITUATED MID-VESSEL IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE ANATOMY WAS TORTUOUS AND THE LESION CALCIFIED. A BALLOON (UNKNOWN BRAND OR SIZE) WAS USED TO PRE-DILATE THE LESION. THE PROMUS ELEMENT STENT 3.5X38MM WAS THEN INTRODUCED. THE DELIVERY SYSTEM FAILED TO CROSS THE LESION. A GUIDELINER DEVICE WAS THEN USED TO HELP THE DEVICE DELIVERY. THE STENT SYSTEM FAILED TO CROSS THE DISTAL SEGMENT OF THE GUIDELINER DUE TO FRICTION. AFTER WITHDRAWAL IT WAS NOTICED THAT THE STENT WAS DAMAGED AND NOT PROPERLY CRIMPED DOWN ON THE DELIVERY SYSTEM. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE AND STENT MOVED ON BALLOON OCCURRED. THE LESION WAS SITUATED MID-VESSEL IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE ANATOMY WAS TORTUOUS AND THE LESION CALCIFIED. A BALLOON (UNKNOWN BRAND OR SIZE) WAS USED TO PRE-DILATE THE LESION. THE PROMUS ELEMENT STENT 3.5X38MM WAS THEN INTRODUCED. THE DELIVERY SYSTEM FAILED TO CROSS THE LESION. A GUIDELINER DEVICE WAS THEN USED TO HELP THE DEVICE DELIVERY. THE STENT SYSTEM FAILED TO CROSS THE DISTAL SEGMENT OF THE GUIDELINER DUE TO FRICTION. AFTER WITHDRAWAL IT WAS NOTICED THAT THE STENT WAS DAMAGED AND NOT PROPERLY CRIMPED DOWN ON THE DELIVERY SYSTEM. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113783 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338350 15414711

    Patients

    Seq Age Sex Outcome Treatment
    1