BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ ESOPHAGEAL

    MDR report key: 2760866 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04391
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE.(B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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 REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED APPROXIMATELY THREE WEEKS PRIOR TO (B)(6), 2012. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2012, THE STENT WAS NOTED TO HAVE MIGRATED INTO THE PATIENT'S STOMACH. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED TO RETRIEVE THE STENT. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT FROM THE PATIENT, THE RETRIEVAL LOOP ON THE STENT BROKE. THE PHYSICIAN WAS ABLE TO REPOSITION THE STENT WITHIN THE ESOPHAGUS USING RAT-TOOTH FORCEPS AND THE STENT WAS LEFT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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 PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516730

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention