BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 997220 · Received February 14, 2008

    Report

    Report Number
    3005099803-2008-00154
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE SUSPECT DEVICE AND THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE 2007 15-MONTH ULTRAFLEX ESOPHAGEAL STENTS PRODUCTS FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    ON 01/18/2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS PLACED (PT GENDER AND WEIGHT UNK) IN 2007. ACCORDING TO THE COMPLAINANT, "THREE DAYS PRIOR, THE PT ENTERED THE HOSP WITH DYSPHAGIA. A GASTROSCOPY WAS PERFORMED AND SHOW[ED] THE STENT IN SITU, BUT PARTIALLY BROKEN IN LENGTH. SOME [OF THE] MESHES OCCLUDED THE LUMEN OF THE STENT." REPORTEDLY, "AS A CORRECTIVE ACTION, A [SECOND ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS] IMPLANTED SUCCESSFULLY." AT THE CONCLUSION OF THE PROCEDURE, THE PT WAS REPORTED TO BE IN "GOOD CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD. M00513750 11282273

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention