BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX

    MDR report key: 3910246 · Received July 2, 2014

    Report

    Report Number
    3005099803-2014-02470
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Adverse Event
    Yes
    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)(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

    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
    386729 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention