BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED ESOPHAGEAL STENT

    MDR report key: 1063766 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00771
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #3005099803-2008-00772. IT WAS REPORTED THAT FOLLOWING AN ESOPHAGEAL STENTING TREATMENT PROCEDURE, A TEAR IN THE STENT COVERING OCCURRED. THE PROCEDURE WAS INDICATED DUE TO A GASTRIC FISTULA. TWO US 12CM ULTRAFLEX COVERED ESOPHAGEAL STENTS HAD BEEN IMPLANTED TO TREAT THE FISTULA. IT IS UNK IF THE DEVICES OVERLAP. THE DEVICES WERE CONSIDERED TO BE FULLY EXPANDED, WELL POSITIONED AND WELL APPOSED. THREE DAYS LATER, TEARS IN THE COVERING OF BOTH PREVIOUSLY IMPLANTED ULTRAFLEX STENTS WAS DISCOVERED. "AN INCREASE OF THE LEAK VOLUME WAS OBSERVED". THE PT HAD ANOTHER UNSPECIFIED STENT IMPLANTED AT AN UNSPECIFIED LOCATION WITHIN THE PREVIOUSLY IMPLANTED STENTS. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED ESOPHAGEAL STENT ESW PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC M00513150 8752362

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR