BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1012344 · Received February 12, 2008

    Report

    Report Number
    9616695-2008-00020
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: NEUROLOGICAL DEFICIT. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT SEVERAL HRS POST AN UNEVENTFUL INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED NOMINAL APHASIA. CT SCAN OF THE HEAD WAS NEGATIVE AND A CAROTID ULTRASOUND SHOWED THAT THE STENT WAS WELL APPOSED IN THE VESSEL AND NO SIGNIFICANT ABNORMALITY WAS OBSERVED. THE PHYSICIAN STATED THAT THE PROBABLE CAUSE WAS MICRO EMBOLI. THE NEUROLOGICAL DEFICIT CONTINUED, AND THE PATIENT REMAINED HOSPITALIZED FOR AN UNK PERIOD OF TIME. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO 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 84 YR Other HEPARIN| EMBOLIC PROTECTION: EMBOLISHED| COUMADIN