BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3100017 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-02983
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE WAS RETURNED, ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE ENTIRE STENT WAS DISLODGED FROM THE CATHETER. THE STENT WAS DAMAGED ALONG ITS LENGTH. THE BALLOON WAS FOLDED AND SHOWED CRIMP MARKS OF THE STENT. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. 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

    PATIENT AGE AT THE TIME OF EVENT: ABOVE 18 YEARS. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT FELL OFF THE DELIVERY SYSTEM. A 2.50X16MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS USED TO CROSS A LESION AT THE LEFT ANTERIOR DESCENDING ARTERY BUT FAILED. THEY REMOVED THE DEVICE AND THE STENT THEN FELL OF THE DELIVERY SYSTEM WHILE REFLUSHING. THE PROCEDURE WAS COMPLETED WITH "SEVERAL PROMUS" DRUG ELUTING STENTS. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT FELL OFF THE DELIVERY SYSTEM. A 2.50X16MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS USED TO CROSS A LESION AT THE LEFT ANTERIOR DESCENDING ARTERY BUT FAILED. THEY REMOVED THE DEVICE AND THE STENT THEN FELL OF THE DELIVERY SYSTEM WHILE REFLUSHING. THE PROCEDURE WAS COMPLETED WITH "SEVERAL PROMUS" DRUG ELUTING STENTS. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201684 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911616250 15849836

    Patients

    Seq Age Sex Outcome Treatment
    1