BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1823442 · Received September 2, 2010

    Report

    Report Number
    3005099803-2010-03750
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE IS UNKNOWN; HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4) - MEDICAL INTERVENTION REQUIRED. (B)(4) - THE REPORTED ISSUE OF SUTURE BROKEN. (B)(4) - THE REPORTED ISSUE OF STENT MIGRATED. (B)(4) - THE REPORTED ISSUE OF STENT DIFFICULTY REMOVING. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED WITHIN THE ESOPHAGUS OF A CANCER PATIENT ON (B)(6) 2010 TO TREAT DYSPHAGIA RESULTING FROM A TUMOR. ACCORDING TO THE COMPLAINANT, TWO WEEKS AFTER THE IMPLANT PROCEDURE (EXACT DATE UNKNOWN) A RADIOGRAPH WAS TAKEN IN PREPARATION FOR RADIATION THERAPY. AT THIS TIME IT WAS DISCOVERED THAT THE ESOPHAGEAL STENT HAD MIGRATED INTO THE PATIENT'S STOMACH. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS, NOR DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2010 AN ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED, WITH THE INTENTION OF PULLING THE STENT BACK UP INTO THE ESOPHAGUS IN ORDER TO RE-BRIDGE THE STRICTURE. AS THE PHYSICIAN WAS RETRIEVING THE STENT WITH FORCEPS, THE SUTURE BROKE. IT WAS REPORTED THAT FOR APPROXIMATELY FORTY FIVE MINUTES, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE STENT. THE PROCEDURE WAS ABORTED AT THIS TIME, AND A MINI-LAPAROSCOPY WAS SCHEDULED IN ORDER TO REMOVE THE STENT. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO PLACE A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE BECAUSE THE STENT DID NOT RESOLVE THE PATIENT'S DYSPHAGIA. ADDITIONAL FOLLOW UP REPORTED THAT THE PHYSICIANS DECIDED NOT TO PERFORM A LAPAROSCOPY NOR PLACE A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. THE PHYSICIANS FELT THAT THE MIGRATED STENT WAS NOT CAUSING ANY ISSUES FOR THE PATIENT. IT WAS IN THEIR OPINION THAT PERFORMING A SURGICAL PROCEDURE TO RETRIEVE THE STENT, OR PLACE THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE, WOULD DELAY THE START OF THE PATIENT'S RADIATION TREATMENT. THEREFORE, THEY DECIDED THAT IT WOULD BE BEST FOR THE PATIENT TO START RADIATION THERAPY AND IF NECESSARY, INTERVENE WITH A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE OR STENT REMOVAL. THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516740

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention