BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3042242 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02367
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS MDR ID# 2134265-2013-02196. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER WAS STUCK IN STENT AND THE STENT WAS DEFORMED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON CATHETER. THEY PERFORMED THE IVUS WITH THE ATLANTIS SR PRO IMAGING CATHETER. THE IMAGING CATHETER BECAME STUCK WITH THE EDGE OF THE STENT AND THE STENT WAS DEFORMED. THE PHYSICIAN THOUGHT THAT THE GUIDEWIRE EXIT PORT OF THIS DEVICE WAS STUCK WITH THE STENT. AN ATTEMPT TO RETRIEVE THE IMAGING CATHETER WAS PERFORMED BY CUTTING THE SHAFT OF THE CATHETER AND REMOVED ITS IMAGING CORE (DRIVE CABLE). THEN THEY ADVANCED THE 0.14 INCH UNKNOWN GUIDEWIRE AND REMOVED THE IMAGING CATHETER FROM THE STENT. TO REPAIR THE DEFORMED STENT, THEY POST-DILATE IT WITH AN UNKNOWN BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145824 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention