BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3020518 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01687
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 25, 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

    (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: 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 A CORONARY STENTING TREATMENT PROCEDURE, A DEFLATION ISSUE OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 4.X8MM, 80% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DEPLOYED A 4X8MM PROMUS ELEMENT STENT. IT WAS THEN OBSERVED THAT THE BALLOON DID NOT DEFLATE PROPERLY. THE PHYSICIAN WAS UNABLE TO GET THE BALLOON BACK INTO THE GUIDE CATHETER AND IT WAS VERY DIFFICULT WITHDRAWING THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123870 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918408400 15616110

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR