BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1984295 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00799
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 19, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF INTRACRANIAL HEMORRHAGE, HYPOTENSION, STENOSIS, TRANSIENT ISCHEMIC ATTACK, AND CEREBROVASCULAR ACCIDENT ARE KNOWN ADVERSE EVENTS LISTED IN THE RX XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST RIGHT INTERNAL CAROTID ARTERY (RICA) STENTING PROCEDURE WITH A XACT STENT, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) WITH LEFT UPPER EXTREMITY WEAKNESS WHICH RESOLVED AFTER A FEW MINUTES. THE HEAD CT AT THAT TIME WAS NEGATIVE. THE FOLLOWING DAY, THE PATIENT HAD WEAKNESS IN THE LEFT ARM. CT SCAN SHOWED CEREBRAL ISCHEMIA AND THE CAROTID ULTRASOUND REVEALED 100% RICA IN-STENT RESTENOSIS. IT WAS FELT THAT THE PATIENT WAS MOST LIKELY A NON-RESPONDER TO PLAVIX; PLAVIX WAS STOPPED AND THE PATIENT WAS TREATED WITH HEPARIN INFUSION, EFFIENT, AND NEOSYNEPHRINE TO KEEP HIS BLOOD PRESSURE GREATER THAN 120 SYSTOLIC, AND UNDERWENT AN ANGIOJET EMBOLECTOMY WHICH RESOLVED ALL SYMPTOMS. SIX DAYS POST PROCEDURE THE PATIENT EXPERIENCED INCREASED WEAKNESS IN THE LEFT UPPER AND LOWER EXTREMITIES WITH LEFT FACIAL DROOP. CT SCAN SHOWED A SMALL LEFT FRONTAL LOBE INTRACEREBRAL BLEED (ICB). HEPARIN, EFFIENT AND ASPIRIN WERE STOPPED AND THE BLEED STABILIZED. THE PATIENT REGAINED SOME OF HIS STRENGTH BUT CONTINUES WITH SOME LONG TERM LEFT SIDED WEAKNESS DUE TO STROKE RELATED TO ICB. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TWELVE DAYS AFTER THE PROCEDURE. THOUGH REQUESTED, 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 0050561

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S