BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1081933 · Received July 23, 2008

    Report

    Report Number
    9616695-2008-00116
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT IDENTIFIED: THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT FRACTURE. SYMPTOMS/AE: NONE. TIME OF MALFUNCTION: AT AN UNKNOWN TIME POST STENT PLACEMENT. IT WAS REPORTED THAT A PATIENT THAT WAS STENTED AT AN UNKNOWN TIME, POST A RESTENOSED CAROTID ENDARTERECTOMY RETURNED AT AN UNKNOWN TIME WITH A STENT FRACTURE. IT IS UNKNOWN IF ANY INTERVENTION WAS PERFORMED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK