BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2232894 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03760
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. A 4.00X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THERE WAS DIFFICULTY ENGAGING THE LESION IN THE LCX AND CROSSING THE LESION. THE STENT DISLODGED INSIDE THE PATIENT HOWEVER IT WAS ABLE TO BE RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312400 14317335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention