BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2032110 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02092
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(6) 2011: MRI = THERE IS MILD FAINT HIGH SIGNAL INTENSITY PRESENT ON T2 AND FLAIR INVOLVING THE MEDIAL LEFT TEMPORAL LOBE AND LEFT PULVINAR OF THE THALAMUS. THIS IS OF UNCERTAIN SIGNIFICANCE. GIVEN PRIOR MORE DISTAL LEFT PCA DISTRIBUTION INFARCT, THIS MIGHT BE ON THAT BASIS. T2 HYPERINTENSITY IN LEFT PULVINAR, LEFT MEDIAL TEMPORAL LOBE AFTER STATUS RESOLUTION. EMBOLIC PROTECTION: EMBOSHIELD NAV 6. THERE WAS NO REPORTED PRODUCT DEFICIENCY. SEIZURES, TIA, VISUAL DISTURBANCES, HYPOTENSION AND NEUROLOGICAL EVENTS ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. 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 THAT AFTER STENT DEPLOYMENT OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED HYPOTENSION THAT RESOLVED WITH A BOLUS OF PHENYLEPHRINE. THE PATIENT WAS THOUGHT TO HAVE HAD A TRANSIENT ISCHEMIC ATTACK (TIA) WITH RIGHT INFERIOR HOMONYMOUS QUADRANTANOPIA. THE TIA WAS LATER DETERMINED TO BE A RESIDUAL EFFECT FROM AN OLD STROKE. THERE WAS NO REPORTED INTERVENTION AND THE EVENT RESOLVED IMMEDIATELY, BUT THE PATIENT WAS NOT DISCHARGED UNTIL FOUR DAYS POST PROCEDURE DUE TO SOCIAL ISSUES. FIVE DAYS AFTER THE STENTING PROCEDURE, THE PATIENT EXPERIENCED A SEIZURE THAT WAS CONTROLLED WITH MEDICATIONS (KEPPRA, VIMPAT, DILANTIN). THE PATIENT CONTINUES TO HAVE MILD RESIDUAL APHASIA. ALTHOUGH THE COMPUTED TOMOGRAPHY (CT) SCAN AND MAGNETIC RESONANCE IMAGING (MRI) SHOWED NO EVIDENCE OF A NEW STROKE, THE PATIENTS CLINICAL PRESENTATION IS SUGGESTIVE OF HYPERPERFUSION SYNDROME. 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 0052061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S