BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1873363 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04523
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT 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, A STENT FRACTURE OCCURRED. THE LESION WAS LOCATED IN A DISSECTED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.0X20MM PROMUS ELEMENT STENT WAS ADVANCED TO AND DEPLOYED IN THE LESION. THE LESION WAS POST-DILATED WITH A 4.0MM NON BSC BALLOON. UNDER ANGIO, THE PHYSICIAN NOTED AN IRREGULARITY OF THE STENT. IVUS WAS USED AND IT WAS SEEN THAT THE STENT HAD FRACTURED "IN THE BODY OF THE STENT." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS PRODUCT IS ONLY (B)(4) 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 H7493911320400

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR