BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED ESOPHAGEAL STENT

    MDR report key: 1153351 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04337
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 DURING AN ESOPHAGEAL STENTING PROCEDURE, THE COVER OF THE ULTRAFLEX STENT WAS "BROKEN". THE PHYSICIAN COMPLETED THE ESOPHAGEAL STENTING PROCEDURE AND WHILE CHECKING THE STENT FOUND THAT THE COVERED STENT WAS "BROKEN". IT APPEARED THAT THE ULTRAFLEX STENT DID NOT COVER THE PATIENT'S ESOPHAGEAL FISTULA. ANOTHER ESOPHAGEAL STENT WAS PLACED OVERLAPPING THE INITIAL STENT TO COVER THE FISTULA. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED ESOPHAGEAL STENT ESW - PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00514650 7903351

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention