BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE ASSURANT BILIARY STENT SYSTEM

    MDR report key: 1790049 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01506
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K011817
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: (DISSECTION), HEAVILY CALCIFICATION), (BRIDGE ASSURANT BILIARY STENT SYSTEM IS APPROVED FOR USE TO MAINTAIN PATENCY OF A BILE DUCT WHICH IS OCCLUDED BY A MALIGNANT TUMOR. NOT APPROVED FOR USE IN EXTERNAL ILIAC). CONCLUSIONS: (HEAVY CALCIFICATION).

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED FROM THE TALENT ON (B)(4) STUDY. A BRIDGE ASSURANT BILIARY STENT SYSTEM, DIAMETER 9MM, LENGTH 40MM WAS INTENDED TO TREAT A DISSECTION IN A PATIENT'S EXTERNAL ILIAC. IT WAS REPORTED THAT, POST IMPLANT OF THE BRIDGE ASSURANT, A FOCAL DISSECTION WAS SEEN IN THE ARTERY WHERE THE STENT WAS PLACED. PRIOR TO THE USE OF THE BRIDGE ASSURANT A TALENT THORACIC HAD BEEN DEPLOYED JUST BELOW THE SUB-CLAVIAN ARTERY WITH NO ISSUE. TWO DISTAL MAIN DEVICES WERE THEN PLACED. A LITTLE DIFFICULTY WAS REPORTED IN GETTING THE DEVICES UP WITHOUT DILATATION AS THE EXTERNAL ILIAC ON THE RIGHT AND COMMON FEMORAL WERE HEAVILY CALCIFIED. POST ARTERIOGRAM REVEALED NO EVIDENCE OF ENDOLEAKS AND THE SUB-CLAVIAN HAD GOOD FLOW WITH GOOD SEALS PROXIMALLY AND DISTALLY. THE ARTERIOGRAM DID SHOW A SHORT SEGMENT DISSECTION IN THE EXTERNAL ILIAC. THE BRIDGE ASSURANT 9X 40MM WAS PLACED OVER THE DISSECTED AREA WITH AN EXCELLENT RESULT. UPON REMOVING ALL SHEATHS AND INTRODUCERS FROM THE RIGHT SIDE A FOCAL DISSECTION WAS SEEN IN THE ARTERY WHERE THE STENT WAS PLACED. ANOTHER STENT WAS USED TO COVER THE DISSECTION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION BY MEDTRONIC. NOTE: BRIDGE ASSURANT BILIARY STENT SYSTEM IS APPROVED FOR USE IN THE BILE DUCT. BRIDGE ASSURANT BILIARY STENT SYSTEM IS NOT APPROVED FOR USE IN EXTERNAL ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGE ASSURANT BILIARY STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention