BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM

    MDR report key: 1812535 · Received August 16, 2010

    Report

    Report Number
    9710478-2010-00100
    Event Type
    Injury
    Date Received
    August 16, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. THE PART AND LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): IN-STENT RESTENOSIS. ONSET OF AE: UNK. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME POST A BELOW THE KNEE STENTING PROCEDURE WITH AN XPERT STENT, THE STENT DEVELOPED IN-STENT RESTENOSIS (ISR). IT IS UNK IF THE ISR WAS TREATED. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1