BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3111217 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03110
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED FOLLOWING DEPLOYMENT. THE 70% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED DISTAL MARGINAL BRANCH. A 3.00X16MM PROMUS ELEMENT PLUS STENT WAS ADVANCED AND DEPLOYED. A 3.50X16MM PROMUS ELEMENT PLUS STENT WAS THEN ADVANCED AND DURING DEPLOYMENT IT WAS NOTED THAT THE PROXIMAL END OF THE 3.00X16MM PROMUS ELEMENT PLUS STENT WAS CRUSHED APPROXIMATELY 3MM. A QUANTUM APEX BALLOON WAS ADVANCED AND POST-DILATION PERFORMED WITH GOOD RESULTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213317 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416300 15728386

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention