BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 2192621 · Received August 5, 2011

    Report

    Report Number
    3005099803-2011-02676
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING AN ESOPHAGEAL STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGEAL STRICTURE DUE TO CANCER. THE PATIENT HAD UNDERGONE A PREVIOUS ESOPHAGOGASTROSTOMY. THE STRICTURE WAS LOCATED FROM 37CM IN THE ESOPHAGUS TO 47CM INTO THE PYLORIC REGION. THE PATIENT ANATOMY WAS NOTED TO BE TORTUOUS AND SEVERAL DILATIONS WERE PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE STENT SYSTEM THROUGH THE DISTAL END OF THE STRICTURE EVEN AFTER THE DILATIONS. IT WAS NOTED THAT THE ENDOSCOPE WAS ABLE TO CROSS THE STRICTURE WITHOUT ISSUE. AFTER SEVERAL ATTEMPTS, THE STENT SYSTEM CROSSED THE LESION; HOWEVER, THE STENT DELIVERY SYSTEM BECAME KINKED. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN DEPLOYING THE STENT AND THE STENT DEPLOYMENT SUTURE WAS NOTED TO BE "TIGHT TO PULL FOR DELIVERY." THE STENT WAS DEPLOYED IN AN IMPROPER POSITION WITHIN THE PATIENT. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT IT WAS KINKED NEAR THE PROXIMAL MARKER. THE STENT WAS LEFT IMPLANTED WITHIN THE PATIENT AND THE PHYSICIAN PLANS TO PERFORM AN ADDITIONAL MEDICAL INTERVENTION AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 13767383

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention