BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1081934 · Received July 23, 2008

    Report

    Report Number
    9616695-2008-00115
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 REVIEW 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 RETURNED AT AN UNKNOWN TIME AND WAS DIAGNOSED AS HAVING A STENT FRACTURE. IT IS UNKNOWN IF ANY INTERVENTION WAS PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK