BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX

    MDR report key: 3910198 · Received July 2, 2014

    Report

    Report Number
    3005099803-2014-02471
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(6). REPORTED EVENT OF STENT COVER DAMAGED. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED IN THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2014-02470 AND 3005099803-2014-02471 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFG REPORT # 3005099803-2014-02470) WAS IMPLANTED IN THE PATIENT¿S ESOPHAGUS IN (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE AFTER A PROXIMAL GASTRIC RESECTION WITH ANASTOMOSES INSUFFICIENCY PERFORMED IN (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A FISTULA. ON (B)(6) 2014, THE PHYSICIAN NOTED A HOLE IN THE STENT COVER AS WELL AS TISSUE INGROWTH. THE PHYSICIAN IMPLANTED ANOTHER ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFG REPORT # 3005099803-2014-02471) WITHIN THE STENT IMPLANTED IN (B)(6) 2013 TO COVER THE HOLE. ON (B)(6) 2014, A HOLE WAS NOTED WITHIN THE COVER OF THE STENT PLACED ON (B)(6) 2014. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387374 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK448

    Patients

    Seq Age Sex Outcome Treatment
    1