BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1133162 · Received August 22, 2008

    Report

    Report Number
    9616695-2008-00128
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 1, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. STROKE IS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE DEVICE AS LISTED IN THE INSTRUCTIONS FOR USE. THERE WAS NO DEVICE MALFUNCTION REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: STROKE. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER THE PLACEMENT OF THE STENT, THE PT HAD RIGHT UPPER EXTREMITY WEAKNESS AND MILD EXPRESSIVE APHASIA, DIAGNOSED AS A STROKE. NEUROLOGY WAS CALLED TO ASSESS SUBJECT IMMEDIATELY AFTER PROCEDURE. A CT SCAN WAS DONE SHOWING NO ACUTE INTRACRANIAL PATHOLOGY.; THE PT WAS SHOWING SOME IMPROVEMENT ONCE OUT OF THE CATHETER LAB. ONE DAY POSTPROCEDURE, AN MRI WAS DONE SHOWING PATCHY REGIONS OF ACUTE NONHEMORRHAGIC CORTICAL AND SUBCORTICAL INFARCTION OF THE LEFT CEREBRAL HEMISPHERE. DURING HOSPITALIZATION, THE PT WAS SEEN BY PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY. EIGHT DAYS POSTPROCEDURE, STATUS SLIGHTLY IMPROVED, THE PT WAS DISCHARGED TO REHABILITATION FACILITY. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 393109

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S EMBOSHIELD EMBOLIC PROTECTION DEVICE| BIVALIRUDIN