BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ ESOPHAGEAL

    MDR report key: 5973719 · Received September 23, 2016

    Report

    Report Number
    3005099803-2016-02785
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (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 COULD NOT 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 ON (B)(6) 2016 THAT A WALLFLEX¿ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE STENT WAS PLACED TO TREAT A LYE STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, DURING AN EGD, THE PHYSICIAN NOTED THAT THE STENT HAD MIGRATED DISTALLY. EVEN THOUGH THE STENT HAD MIGRATED, IT STILL REMAINED IN THE PATIENT¿S ESOPHAGUS AND THE PHYSICIAN FELT COMFORTABLE LEAVING THE STENT IN PLACE. 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 STABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625793 WALLFLEX¿ ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK477

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR