BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    MDR report key: 1885100 · Received October 28, 2010

    Report

    Report Number
    3005099803-2010-04573
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) A PORTION OF THE CATHETER DELIVERY SYSTEM DETACHED. 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

    *NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04572 PERTAINS TO THE UNKNOWN WALLFLEX STENT WHICH WAS IMPLANTED ROUGHLY 6 MONTHS AGO. MANUFACTURER REPORT # 3005099803-2010-04753 PERTAINS TO THE WALLFLEX BILIARY RX COVERED STENT WHICH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN WALLFLEX BILIARY STENT AND A WALLFLEX BILIARY RX COVERED STENT WERE USED TO TREAT A POST-LIVER TRANSPLANT ANASTOMOTIC STRICTURE. ACCORDING TO THE COMPLAINANT, THE UNKNOWN WALLFLEX STENT WAS PLACED APPROXIMATELY 6 MONTHS PRIOR TO (B)(6) 2010. AT LATER DATE, IT WAS NOTED THAT THE STENT HAD MIGRATED. DURING A PROCEDURE ON (B)(6) 2010 TO REMOVE THE STENT, IT GOT STUCK HALFWAY; THE PHYSICIAN SUSPECTED THAT IT WAS EITHER A STAPLE OR A CLIP ON WHICH THE STENT GOT CAUGHT. THE PHYSICIAN ATTEMPTED TO USE RATCHET FORCEPS TO REMOVE THE DEVICE, BUT WAS STILL UNSUCCESSFUL. FINALLY, HE USED AN ARGON PLASMA COAGULATION (APC) LASER TO CUT THE STENT IN TWO; HALF OF THE STENT WAS REMOVED, WHILE THE OTHER HALF WAS LEFT IN THE BILE DUCT. DURING THIS SAME PROCEDURE, THE PHYSICIAN DECIDED TO TRY AND PLACE THE WALLFLEX BILIARY RX COVERED STENT IN THE COMMON BILE DUCT. WHILE DEPLOYING THE STENT, THE DISTAL TIP OF THE DELIVERY SYSTEM GOT CAUGHT ON THE STENT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, THE INNER SHEATH DETACHED FROM THE REST OF THE DELIVERY SYSTEM AND FELL INTO THE PATIENT. THIS PORTION OF THE DELIVERY SYSTEM WAS REMOVED WITH FORCEPS WITHOUT ISSUE. DESPITE THIS ISSUE, THIS STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. AT THIS POINT, THE PHYSICIAN PLANS TO REMOVE THE OTHER HALF OF THE INITIAL STENT AT A LATER DATE. THE PATIENT IS REPORTED TO BE GOOD CONDITION. THE ANATOMY WAS NOTED TO BE TORTUOUS, BUT NOT OUT OF THE ORDINARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention