BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3881448 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03483
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO DEFECTS ON BALLOON SECTIONS OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND THAT THERE WERE VARIOUS HYPOTUBE KINKS ALONG THE LENGTH OF THE UNIT. THERE WAS DAMAGE NOTED IN THE PROXIMAL END OF THE STENT, THE STENT WAS BUNCHED AND MISALIGNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. IT WAS REPORTED THAT SHAFT KINKED OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE LOADING THE 2.75MM X 38MM PROMUS ELEMENT¿ PLUS STENT IT WAS NOTED THAT THE END CLOSEST TO THE HUB WAS BENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, ADDITIONAL INFORMATION REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358008 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438270 16288999

    Patients

    Seq Age Sex Outcome Treatment
    1