BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1063231 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01733
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF HISTORICAL TRENDING, REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 2134265-2008-01732. IT WAS REPORTED THAT DURING AN UNSPECIFIED BILIARY PROCEDURE, THE STENT FAILED TO EXPAND, A STENT DISLODGEMENT, AND A BALLOON MATERIAL DETACHMENT OCCURRED. THE APPROXIMATELY 2CM, "SEVERELY CALCIFIED", LESION WAS LOCATED IN THE LEFT HEPATIC DUCT "NEAR THE TRIAD MERGED AREA". THE PERCENT OF THE STENOSIS IS UNKNOWN. THE LESION WAS NOT PRE-DILATED. THE EXPRESS BILIARY 10MM X 60MM X 75CM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED, HOWEVER, THE PHYSICIAN NOTED THAT THE STENT HAD NOT FULLY EXPANDED. UPON ATTEMPTING TO REMOVE THE SDS FROM THE PT, DIFFICULTY WAS EXPERIENCED AND THE PHYSICIAN WAS REQUIRED TO MAKE AN INCISION AT THE ACCESS SITE TO REMOVE THE DEVICE. BECAUSE OF THE INCISION AT THE ACCESS SITE, THE PHYSICIAN DID NOT ATTEMPT TO POST-DILATE THE STENT. AN INDWELLING 7FR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) TUBE WAS PLACED IN THE LEFT HEPATIC DUCT AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PT HAD COMPLAINED OF "SOME PAIN", HOWEVER, THE PATIENT'S STATUS WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE. IT WAS THE PHYSICIAN'S OPINION THAT THE STENT HAD NOT FULLY EXPANDED DUE TO SEVERE CALCIFICATION OF THE STENOSIS. APPROXIMATELY 3 WEEKS LATER, THE PT UNDERWENT A SECOND STENT PLACEMENT PROCEDURE. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND THE PTBD TUBE WAS REMOVED. THE PHYSICIAN INSERTED AN UNSPECIFIED 7FR X 10CM SHEATH. AN UNSPECIFIED 4FR X 25CM SHEATH WAS INTRODUCED INTO THE 7FR X 10 CM SHEATH TO EXAMINE THE STENOSIS UNDER FLUOROSCOPY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO THE PREVIOUSLY PLACED STENT, AFTER WHICH THE 7FR AND 4FR SHEATHS WERE BOTH REMOVED. IN AN EFFORT TO "MAKE SOME SPACE" TO BE ABLE TO PASS A STENT DELIVERY SYSTEM THROUGH THE PREVIOUSLY PLACED STENT, THE 7FR PTBD TUBE STENT WAS ADVANCED OVER THE GUIDE WIRE. THE 7FR SHEATH WAS RE-INTRODUCED AND THE EXPRESS BILIARY 10MM X 60MM X 75CM SDS WAS ADVANCED, HOWEVER, AFTER PASSING A "HALF CURVED AREA", THE SDS WAS UNABLE TO BE ADVANCED FURTHER. UPON ATTEMPTING TO REMOVE THE ENTIRE SYSTEM FROM THE PT, THE STENT "WAS CAUGHT" AND DISLODGED FROM THE SDS AND REMAINED IN THE "CURVED AREA". THE PHYSICIAN APPLIED FORCE TO REMOVE THE DEVICE. IT WAS NOTED THAT THE PT EXPERIENCED "SOME PAIN WHEN [THE PHYSICIAN] MANIPULATED TO PUSH THE DELIVERY SYSTEM" AND THERE WAS "SOME BLEEDING" FROM THE ACCESS SITE. THE PHYSICIAN ADVANCED AN UNSPECIFIED 4MM MICROSNARE AND WAS ABLE TO WITHDRAW THE DISLODGED STENT TO "NEAR THE SURFACE OF THE PT'S BODY". AN ADDITIONAL INCISION WAS MADE AT THE ACCESS SITE AND THE DISLODGED STENT WAS SUCCESSFULLY REMOVED WITH A FORCEPS. IN AN ATTEMPT TO USE THE BALLOON OF THE SDS TO POST-DILATE THE STENT PLACED IN THE PREVIOUS PROCEDURE, THE PHYSICIAN ADVANCED THE SDS TO THE PREVIOUSLY PLACED STENT; HOWEVER, THE SDS WAS UNABLE TO CROSS THE STENT AND WAS REMOVED. A 7FR PTBD TUBE STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INTERVENTION. IT WAS REPORTED THAT UPON COMPLETION OF THE PROCEDURE, THE PT "SEEMED TO BE NOT IN PAIN". IT WAS NOTED THAT THE PHYSICIAN THOUGHT THAT "IT WOULD BE POSSIBLE THAT SOME PART OF THE BALLOON REMAINED INSIDE THE PT DURING REMOVAL OF THE DELIVERY SYSTEM WITH FORCE". IT WAS THE PHYSICIAN'S OPINION THAT THE FIRST STENT'S FAILURE TO EXPAND WAS NOT PRODUCT RELATED BUT RELATED TO PT OR PROCEDURAL FACTORS. THE PHYSICIAN PLANS TO ATTEMPT A THIRD PROCEDURE TO POST-DILATE THE UN-EXPANDED STENT AFTER THE PT HAS HAD ADEQUATE TIME TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention