BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2840464 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07114
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    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 COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED PROXIMAL STENT DAMAGE. THE STRUTS AT THE PROXIMAL EDGE WERE BUNCHED AND MISALIGNED. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS RIGHT CORONARY ARTERY TO THE MID RIGHT CORONARY ARTERY. A PROMUS ELEMENT, MR, 3.00X16MM STENT FAILED TO CROSS THE TARGET LESION AND ENCOUNTERED DIFFICULTY IN REMOVING THE PROMUS ELEMENT STENT DELIVERY SYSTEM. IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS RIGHT CORONARY ARTERY TO THE MID RIGHT CORONARY ARTERY. A PROMUS ELEMENT, MR, 3.00 X 16 MM STENT FAILED TO CROSS THE TARGET LESION AND ENCOUNTERED DIFFICULTY IN REMOVING THE PROMUS ELEMENT STENT DELIVERY SYSTEM. IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 15145309

    Patients

    Seq Age Sex Outcome Treatment
    1