BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2840476 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07029
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PATIENT WAS SCHEDULED FOR A ROTABLATOR PROCEDURE. THE PHYSICIAN USED A 7FR SYSTEM WITH AN EXTENSION CATHETER FOR SUPPORT AND THE ROTABLATOR WAS USED TWICE. NEXT THE PHYSICIAN ATTEMPTED TO PASS A 4.0 X 20 MM PROMUS ELEMENT PLUS STENT INTO THE SUPPORT CATHETER BUT MET RESISTANCE AT THE OPENING OF THE SUPPORT CATHETER, SO HE REMOVED THE DEVICE AND FOUND THE STENT WAS FLARED. THIS OCCURRED AT THE PREPARATION STEP, THE STENT NEVER ENTERED THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420400 15258802

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR