BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE ASSURANT BILIARY STENT SYSTEM

    MDR report key: 1936091 · Received December 13, 2010

    Report

    Report Number
    2953200-2010-02546
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K011817
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (DISLODGEMENT), (PULLING BACK OF UNDEPLOYED DEVICES), (BRIDGE ASSURANT IS APPROVED TO MAINTAIN PATENCY OF A BILE DUCT WHICH IS OCCLUDED BY A MALIGNANT TUMOR). EVALUATION, CONCLUSIONS: (PULLING BACK OF UNDEPLOYED DEVICES).

    Description of Event or Problem · 1

    A BRIDGE ASSURANT BILIARY STENT SYSTEM, DIAMETER 9MM, LENGTH 30MM WAS USED TO TREAT A LESION IN A PATIENT'S LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THAT ATTEMPTS TO CROSS THE LESION WERE UNSUCCESSFUL AND THE STENT BECAME DISLODGED DURING WITHDRAWAL PAST THE ILIAC BIFURCATION. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE STENT. THE PATIENT WAS SENT FOR SURGERY. NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGE ASSURANT BILIARY STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR GALWAY NA 0001860007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention