BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3103314 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03336
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 14, 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 IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS DAMAGED. STRUT ROWS FROM THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND BENT OUTWARDS DISTALLY. 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 HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END OF LEFT ANTERIOR DESCENDING(LAD) ARTERY TO THE MIDDLE OF LAD AND EXTENDING TO THE FIRST DIAGONAL LAD. A 3.00 X 16MM PROMUS ELEMENT STENT WAS USED FOR THE CULOTTE STENTING TECHNIQUE. DURING INSERTION OF THE COMPLAINT DEVICE RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS THEN REMOVED AND REVEALED PROXIMAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 16 MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END OF LEFT ANTERIOR DESCENDING(LAD) ARTERY TO THE MIDDLE OF LAD AND EXTENDING TO THE FIRST DIAGONAL LAD. A 3.00 X 16MM PROMUS ELEMENT STENT WAS USED FOR THE CULOTTE STENTING TECHNIQUE. DURING INSERTION OF THE COMPLAINT DEVICE RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS THEN REMOVED AND REVEALED PROXIMAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 16 MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204369 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 15478926

    Patients

    Seq Age Sex Outcome Treatment
    1