BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1914253 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05056
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT A PERFORATION WITHIN THE DISTAL ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE WALLFLEX STENT WAS IMPLANTED ON (B)(6) 2010 TO TREAT A PERFORATION THAT WAS CAUSED BY A DILATATION PROCEDURE (THE DILATATION WAS PERFORMED AT ANOTHER UNKNOWN LOCATION). THE WALLFLEX STENT WAS PLACED SUCCESSFULLY AND WITHOUT ISSUE. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL IN (B)(6), WHERE SHE EXPIRED DUE TO "INTERNAL BLEEDING." THE SOURCE OF THE BLEEDING WAS UNKNOWN. ALTHOUGH AN EXACT CAUSE OF DEATH COULD NOT BE DETERMINED, DR (B)(6) WHO IMPLANTED THE WALLFLEX STENT, FELT THAT THIS DEVICE WAS NOT RELATED TO THE PATIENT'S BLEEDING OR DEATH. DR (B)(6) ADDED THAT THE PATIENT WAS VERY SICK AND HAD SEVERAL CO-MORBIDITIES, ALONG WITH IMPACTIONS WITHIN THE ESOPHAGUS THAT REQUIRED A FEEDING TUBE; THE WALLFLEX STENT WAS MEANT AS A PALLIATIVE MEASURE. IT SHOULD BE NOTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. AS THIS WAS USED TO TREAT A PERFORATION, THIS HAS BEEN IDENTIFIED AS AN OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516740

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death