BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 2200897 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02675
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS USED DURING A EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS POSITIONED LOWER IN THE PATIENT THAN THE PHYSICIAN WANTED. AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN GRABBED THE RETRIEVAL SUTURE WITH RAT TOOTH FORCEPS TO TRY AND REPOSITION THE STENT, THE STRING BROKE, AND HE WAS UNSUCCESSFUL IN REPOSITIONING THE STENT. ON (B)(6) 2011, THE PHYSICIAN BROUGHT THE PATIENT BACK IN AND TRIED AGAIN UNSUCCESSFULLY TO REPOSITION THE STENT. THE PHYSICIAN PLACED A DIFFERENT STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention