BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM

    MDR report key: 2022885 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00830
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PARTIALLY COVERED STENT WAS IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT, DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A FIVE CENTIMETER LESION IN THE DISTAL ESOPHAGUS AS A RESULT OF ESOPHAGEAL CANCER. DURING THE STENT PLACEMENT PROCEDURE ON (B)(6) 2010, NO DILATION WAS PERFORMED, AS THE PATIENT'S ANATOMY WAS NOT TORTUOUS. POST PROCEDURE, ON (B)(6) 2011, THE PATIENT PRESENTED WITH MINOR BLEEDING. NO INTERVENTION WAS PERFORMED, AS THE BLEEDING RESOLVED. THE FOLLOW DAY, ON (B)(6) 2011, IT WAS REPORTED THAT THE STENT HAD MIGRATED FROM THE PATIENT'S ESOPHAGUS INTO THE STOMACH. NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT, AS THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT AS IS TO PASS NATURALLY. ADDITIONALLY, IT WAS REPORTED THAT THE STENT HAS NOT PASSED; AND NO INTERVENTION IS PLANNED. THERE WERE NO SERIOUS INJURIES REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516930 13890994

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR