BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3961977 · Received July 28, 2014

    Report

    Report Number
    3005099803-2014-02654
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO REPORT THE 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 THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULL COVERED STENT WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. THIS WAS TO TREAT A 4CM MID-ESOPHAGEAL STRICTURE DUE TO LUNG CANCER. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO THE PROCEDURE. REPORTEDLY, THE STRICTURE WAS VERY TIGHT AND THE PATIENT'S CONDITION WAS UNSTABLE, VERY ILL AND MALNOURISHED. THE PHYSICIAN ALSO NOTED THAT THE PATIENT¿S STABILITY GOING INTO THE PROCEDURE WAS COMPROMISED. DURING THE PROCEDURE, THE STENT PERFORATED THROUGH THE RIGHT SIDE OF THE ESOPHAGUS, PROXIMAL TO THE LOWER GASTRO-ESOPHAGEAL SPHINCTER AND THE STENT WAS FULLY DEPLOYED THROUGH THE ESOPHAGEAL WALL. THE PHYSICIAN REMOVED THE STENT AND THE PERFORATION CAUSED AIR TO GO TO THE CHEST CAVITY AND THE PATIENT DIED. ACCORDING TO THE PHYSICIAN, REMOVING THE STENT FOLLOWING THE PERFORATION CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437729 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516730

    Patients

    Seq Age Sex Outcome Treatment
    1 Death