BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3111951 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03352
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    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 EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND SEVERAL SLIGHT KINKS ALONG THE WORKING LENGTH OF THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. THE BALLOON AND TIP SECTIONS 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 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, A STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY . THE LESION WAS PREDILATED. A 2.50X20MM PROMUS ELEMENT DRUG ELUTING STENT DELIVERY SYSTEM WAS ADVANCED BUT UNABLE TO CROSS THE LESION. FOLLOWING REMOVAL, IT WAS THOUGHT THAT THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE A STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY . THE LESION WAS PREDILATED. A 2.50X20MM PROMUS ELEMENT DRUG ELUTING STENT DELIVERY SYSTEM WAS ADVANCED BUT UNABLE TO CROSS THE LESION. FOLLOWING REMOVAL, IT WAS THOUGHT THAT THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213136 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 15025909

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO| BALLOON CATHETER: EMERGE| GUIDING CATHETER: MACH1| GUIDEWIRE: RUNTHROUGH| STENT: RI| INFLATION DEVICE:ENCORE