BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1031790 · Received April 21, 2008

    Report

    Report Number
    2134265-2008-01147
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT FRACTURE OCCURRED. THE PATIENT HAD A 2.5X12MM EXPRESS2 BARE METAL STENT IMPLANTED IN AN UNKNOWN LOCATION. AT AN UNSPECIFIED TIME LATER, IT WAS REPORTED THAT THE "STENT FRACTURED INSIDE THE PATIENT". THERE WERE NO PATIENT COMPLICATIONS REPORTED; HOWEVER, THE PATIENT'S CURRENT CONDITION IS UNKNOWN. DESPITE MULTIPLE ATTEMPTS TO REQUEST ADDITIONAL INFORMATION, NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other