BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1181095 · Received September 29, 2008

    Report

    Report Number
    3005099803-2008-04918
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL STENTING TREATMENT PROCEDURE, PARTIAL STENT DEPLOYMENT OCCURRED. THE TARGET STRICTURE WAS IN THE MID ESOPHAGUS. AN ULTRAFLEX ESOPH NG DISTL CVD STN 18X10 STENT HAD BEEN ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT, THE STENT WAS UNABLE TO BE DEPLOYED BEYOND 2CM AS THE STENT SUTURE APPEARED TO BE WRAPPED AROUND THE STENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT 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 NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC M00513730 11799428

    Patients

    Seq Age Sex Outcome Treatment
    1