BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2992682 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01311
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 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 MFR: INITIAL VISUAL EXAMINATION NOTED PROXIMAL STENT STRUT DAMAGE, AS AN INDIVIDUAL STRUT APPEARED STRETCHED, INTERRUPTING THE PROFILE OF THE CRIMPED STENT. A SEVERE KINK WAS ALSO NOTED APPROXIMATELY 87MM DISTAL FROM THE CATHETERS STRAIN RELIEF. NO FURTHER DAMAGE WAS NOTED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. 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 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 2.25X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED. IT WAS NOTED THAT SHAFT KINKS OCCURRED AND PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 2.25X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM AND WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED. IT WAS NOTED THAT SHAFT KINKS OCCURRED AND PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97869 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 15664257

    Patients

    Seq Age Sex Outcome Treatment
    1