BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1936306 · Received December 22, 2010

    Report

    Report Number
    3004742046-2010-00620
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CONCOMITANT MEDICAL PRODUCTS: EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4), LOT 0072851), ANGIOMAX. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF CEREBROVASCULAR ACCIDENT (STROKE) IS A KNOWN ADVERSE EVENT LISTED IN THE XACT INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    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 CEREBROVASCULAR ACCIDENT, HEMORRHAGE AND DEATH ARE KNOWN ADVERSE EVENT LISTED IN THE 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 TRIAL THAT ON (B)(6) 2010, 26 DAYS POST UNEVENTFUL XACT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY (RICA), THE PATIENT EXPERIENCED A LEFT SIDED STROKE THE EVENING AFTER A PLANNED CABG FOR RECURRENT GRAFT STENOSIS. THE RICA STENTING PROCEDURE HAD BEEN PERFORMED FOR STABILIZATION BEFORE THE CABG WAS PERFORMED ON (B)(6) 2010. THAT POST-OPERATIVE AFTERNOON THE PATIENT DEVELOPED RECURRENT VENTRICULAR DYSRHYTHMIAS AND HYPOTENSION, TREATED WITH CARDIOVERSION, BALLOON PUMP, INOTROPES AND VASOPRESSORS. INITIAL NEUROLOGICAL ASSESSMENT SHOWED THAT THE PATIENT WITHDREW ALL FOUR EXTREMITIES TO STIMULI. LATER ASSESSMENT SHOWED THAT HE WOULD NOT MOVE HIS LEFT SIDE. NO TREATMENT WAS GIVEN FOR THE NEUROLOGIC DEFICITS. ASYSTOLE OCCURRED, UNRESPONSIVE TO CPR, AND THE PATIENT DIED ON THE MORNING OF (B)(6) 2010. ACCORDING TO THE DEATH CERTIFICATE THE PRIMARY CASE OF DEATH WAS REFRACTORY VENTRICULAR TACHYCARDIA/FIBRILLATION. A LEFT SIDED STROKE WAS DOCUMENTED BY THE PRONOUNCING PHYSICIAN ON THE DEATH CERTIFICATE. IN THE OPINION OF THE INVESTIGATOR, THE DYSRHYTHMIAS WERE PRE-EXISTING THE CAROTID PROCEDURE AND THE DEATH WAS UNRELATED TO THE CAROTID STENT OR PROCEDURE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES DEATH WAS LIKELY DUE TO IPSILATERAL, HEMORRHAGIC STROKE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0071661

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| S