BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3072374 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02456
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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

    SAME CASE AS MFR ID # 2134265-2013-02457, 2134265-2013-02458. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). A NON-BSC EMBOLIC PROTECTION DEVICE WAS PLACED IN THE DISTAL LESION. THREE UNKNOWN SIZE PROMUS ELEMENT PLUS STENTS WERE IMPLANTED. FOLLOWING DEPLOYMENT OF THE STENTS THE EMBOLIC PROTECTION DEVICE WAS WITHDRAWN AND CAUGHT ON THE DEPLOYED STENT STRUTS, ALL THREE IMPLANTED STENTS WERE DEFORMED. THE DEFORMED STENTS WERE POST-DILATED WITH A UNKNOWN BALLOON AND RESTORED BLOOD FLOW. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174430 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMBOLIC PROTECTION: SPIDER