BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3994175 · Received August 8, 2014

    Report

    Report Number
    3005099803-2014-02720
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 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 THAT A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A GASTRIC FISTULA. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. NO ISSUES WERE REPORTED DURING STENT PLACEMENT. ON (B)(6), 2014, DURING A ROUTINE CHECK-UP, AN X-RAY WAS PERFORMED AND THE PHYSICIAN NOTED THAT THE STENT HAD MIGRATED INTO THE GASTRIC SLEEVE. THE PHYSICIAN PULLED THE STENT BACK INTO THE DISTAL END OF THE ESOPHAGUS/PROXIMAL END OF THE STOMACH USING AN ACHALASIA BALLOON. THE PHYSICIAN NOTED THAT THE STENT WAS DAMAGED BUT WAS LEFT IMPLANTED. ON (B)(6) 2014, DURING A PLANNED STENT REMOVAL, THE PHYSICIAN GRASPED THE BOTTOM OF THE STENT AND PULLED, CAUSING THE STENT TO FOLD INSIDE OUT. SOME OF THE MUCOSA WAS TORN DURING THE STENT REMOVAL. REPORTEDLY, NO INTERVENTIONS WERE DONE TO ADDRESS THE TORN MUCOSA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467329 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention