BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2962188 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00665
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE DEVICE FOUND NO ISSUES WITH THE RETURNED DEVICE. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE NON-CALCIFIED RIGHT ATRIOVENTRICULAR BRANCH. PRE-DILATION WAS PERFORMED WITH A 2.25 X 15 MM NON-BSC BALLOON INFLATED TO 20 ATMS. NEXT USING A BUDDY WIRE AND ANCHOR TECHNIQUE, A 2.25 X 24 MM PROMUS ELEMENT PLUS STENT WAS ADVANCED FOR TREATMENT BUT WAS NOT ABLE TO CROSS THE MODERATELY TORTUOUS SECTION OF THE MID RIGHT CORONARY ARTERY. UPON REMOVAL, IT WAS NOTED THE STENT GOT FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE NON-CALCIFIED RIGHT ATRIOVENTRICULAR BRANCH. PRE-DILATION WAS PERFORMED WITH A 2.25X15MM NON-BSC BALLOON INFLATED TO 20 ATMS. NEXT USING A BUDDY WIRE AND ANCHOR TECHNIQUE, A 2.25X24MM PROMUS ELEMENT PLUS STENT WAS ADVANCED FOR TREATMENT BUT WAS NOT ABLE TO CROSS THE MODERATELY TORTUOUS SECTION OF THE MID RIGHT CORONARY ARTERY. UPON REMOVAL, IT WAS NOTED THE STENT GOT FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64664 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424220 15680312

    Patients

    Seq Age Sex Outcome Treatment
    1 ASAHI SION GUIDE WIRE