BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1946352 · Received January 4, 2011

    Report

    Report Number
    3005099803-2011-00009
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT DEVICE REMAINS IMPLANTED, IT 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 IMPLANTED WITHIN THE DISTAL ESOPHAGUS ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH PAIN IN THE VENTRICLE OF THE STOMACH. ON (B)(6), 2010, THE PHYSICIAN DISCOVERED THAT THE STENT HAD MIGRATED DOWN INTO THE VENTRICLE OF THE STOMACH; ONLY APPROXIMATELY 40% OF THE STENT REMAINED IN THE ESOPHAGUS. ON (B)(6), 2010, THE PHYSICIAN PULLED THE STENT BACK UP INTO THE CORRECT POSITION. THE STENT DID NOT NEED TO BE EXPLANTED.THE PATIENT WAS IN STABLE CONDITION FOLLOWING THIS PROCEDURE. THE PHYSICIAN ADDED THAT ESOPHAGUS WAS A LITTLE SORE AND RED DUE TO THE STENT MIGRATION, BUT NO PERFORATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516730 13779171

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention