BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2001213 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01167
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS INSIDE THE PATIENT. TIA AND STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, TIA AND STROKE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT 15 DAYS AFTER THE IMPLANTATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY (LICA), THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) WITH NUMBNESS/TINGLING ON THE RIGHT UPPER EXTREMITY AND THE RIGHT SIDE OF THE FACE. THE EVENT RESOLVED IN APPROXIMATELY TWENTY MINUTES. DURING THE HOSPITALIZATION FOR THE TIA, 23 DAYS AFTER THE CAROTID STENTING PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH RECURRENT RIGHT SIDED WEAKNESS AND APHASIA. THE WEAKNESS CONTINUES, BUT OVERALL THE PATIENTS CONDITION HAS IMPROVED. THERE WAS NO REPORTED INTERVENTION. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2011. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0102661

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| S