BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3052081 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02138
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 15, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THE SHAFT OF THE DEVICE WAS KINKED AT 45MM PROXIMAL TO THE TIP OF THE DEVICE. THE AREA OF THE KINK WAS FLATTENED FOR ABOUT 1MM IN LENGTH AND HAD SEVERAL SMALLER KINKS ALONG ITS LENGTH. THE HYPOTUBE WAS KINKED AT 330MM AND 750MM DISTAL TO THE STRAIN RELIEF. SEVERAL SMALLER KINKS WERE ALSO NOTED ALONG THE LENGTH OF THE DEVICE. THE FIRST ROW ON THE DISTAL END OF THE STENT WAS MISALIGNED. THE BALLOON AND THE TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. DUE TO THE DAMAGE NOTED TO THE LUMEN OF THE DEVICE IT WAS NOT POSSIBLE TO INSERT A 0.015 INCH PRODUCT MANDREL. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WHEN A LEAK WAS NOTED IN THE SHAFT 19MM PROXIMAL TO THE PROXIMAL EDGE OF THE STENT. A TEAR WAS NOTED IN THE LUMEN 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 ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE SHAFT WAS KINKED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL AND DISTAL LEFT CIRCUMFLEX ARTERY. THE TARGET LESION WAS ABLATED WITH ROTATIONAL ATHERECTOMY. THE 3.00X20MM PROMUS ELEMENT STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. AFTER THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156931 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 15615538

    Patients

    Seq Age Sex Outcome Treatment
    1