BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3013449 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-02227
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A SHAFT HYPOTUBE BREAK LOCATED 122.5CM FROM THE CATHETER STRAIN RELIEF. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED SEVERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, 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 DELIVERY DEVICE WAS RETURNED WITHOUT THE HUB. 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

    REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION AND THE CATHETER FRACTURED AT THE HUB. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 25X32MM LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH A 2.X12MM MAVERICK BALLOON CATHETER. THEN, PHYSICIAN ADVANCED THE 2.50X32MM PROMUS ELEMENT STENT DELIVERY SYSTEM WITH FORCE AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED AND IT WAS NOTED TO BE FRACTURED AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED SHAFT HYPOTUBE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115979 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332250 15327942

    Patients

    Seq Age Sex Outcome Treatment
    1