BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT

    MDR report key: 1250398 · Received December 3, 2008

    Report

    Report Number
    3005099803-2008-06908
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS FOLLOWING PLACEMENT OF A WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT, THE STENT HAD MIGRATED WITH "AN ABUNDANT AMOUNT OF TISSUE GRANULATION ABOVE AND BELOW THE STENT." REPORTEDLY, THERE WERE NO POSITIONING ISSUES ENCOUNTERED DURING THE PLACEMENT PROCEDURE AND THAT THE STENT APPEARED TO BE WELL POSITIONED AFTER THE DELIVERY SYSTEM WAS REMOVED. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPOSITIONED THE STENT; THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AFTER REMEDYING THE SITUATION, THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD. M00516910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention