BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2972789 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00992
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (B)(4) FOR THE REPORTED ISSUE OF STENT PREMATURELY DEPLOYED. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS 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 ENTERAL COLONIC STENT WAS IMPLANTED WITHIN A PATIENT ON (B)(6) 2013 DURING A GASTROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT PREVIOUSLY UNDERWENT A BILLROTH II SURGERY AND SUBSEQUENTLY DEVELOPED AN ANASTO-MOTIC STRICTURE. THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF THE ANASTOMOTIC STRICTURE. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS. PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTED THAT DUE TO THE NATURE OF THE ANATOMY, THE STRICTURE COULD NOT BE REACHED USING A GASTROSCOPE. THEREFORE, THE PHYSICIAN ELECTED TO USE A COLONOSCOPE AND PLACE A WALLFLEX COLONIC STENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED WITHIN THE TARGET LESION. HOWEVER, THE STENT WAS DIFFICULT TO DE-PLOY AND AS A RESULT, THE WHITE HANDLE DETACHED. ACCORDING TO THE USER, WHEN APPROXIMATELY 50% OF THE STENT WAS DEPLOYED, IT PREMATURELY RELEASED INTO THE PATIENT AND WAS IMPLANTED IN THE WRONG LOCATION. THE STENT WAS LEFT IMPLANTED AND A SECOND WALLFLEX ENTERAL COLONIC STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH THESE TWO STENTS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE. IT IS IMPORTANT TO NOTE THAT PER THE DIRECTIONS FOR USE (DFU) OF THE WALLFLEX ENTERAL COLONIC STENT SYSTEM, THE "DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF COLONIC STRICTURES PRODUCED BY MALIGNANT NEOPLASM AND TO RELIEVE LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY IN PATIENTS WITH MALIGNANT STRICTURES". HOWEVER, ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT AN ANASTOMOTIC STRICTURE FOLLOWING BILLROTH II SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77120 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565040 0015060309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention