BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1854320 · Received October 5, 2010

    Report

    Report Number
    3005099803-2010-04227
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 FULLY COVERED ESOPHAGEAL STENT WAS IMPLANTED INTO THE PATIENT AND THEN MIGRATED EITHER PROXIMALLY OR DISTALLY. THIS WAS A GENERAL COMPLAINT AND THE PHYSICIAN DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PATIENT OR EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK477

    Patients

    Seq Age Sex Outcome Treatment
    1