BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2617079 · Received June 14, 2012

    Report

    Report Number
    2024168-2012-03796
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    March 29, 2012
    Report Date
    May 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: STENT: XACT (82086-01/1042161); BIVALIRUDIN. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF EMBOLISM, NEUROLOGICAL DEFICIT DYSFUNCTION, AND OCCLUSION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS OF CAROTID PROCEDURES AS LISTED IN THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY CALCIFIED LEFT INTERNAL CAROTID ARTERY, THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE WAS ADVANCED INTO THE PATIENT ANATOMY AND THE FILTER WAS DEPLOYED. A 9-7 X 40 MM XACT STENT SYSTEM WAS THEN ADVANCED AND THE STENT DEPLOYED. AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED NO REFLOW AND EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH SYMPTOMS OF APHASIA AND HEMIANOPIA. A NON-ABBOTT ASPIRATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY MULTIPLE TIMES UNTIL TIMI 2 FLOW WAS NOTED. AN ATTEMPT WAS MADE TO REMOVE THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE; HOWEVER, THE FILTER COULD NOT BE PULLED INTO THE RECOVERY CATHETER. THE ENTIRE SYSTEM WAS REMOVED AS A SINGLE UNIT. ONCE THE DEVICE WAS PULLED INTO THE DESCENDING AORTA, FLOW IMPROVED IMMEDIATELY AND THE PATIENT'S SYMPTOMS RESOLVED. THE FILTER WAS NOTED TO BE FULLY OF SOFT PLAQUE DEBRIS WHEN REMOVED FROM THE PATIENT ANATOMY. POST PROCEDURE, THE PATIENT RECEIVED A BLOOD TRANSFUSION TO TREAT CHRONIC ANEMIA. IT WAS NOTED THAT THE PATIENT'S NEUROLOGICAL SYMPTOMS OF APHASIA AND HEMIANOPIA RETURNED. LOW DOSE HEPARIN WAS ADMINISTERED AND A NEUROLOGICAL CONSULT WAS OBTAINED. PER THE NEUROLOGIST, THE PATIENT LIKELY HAD AN EMBOLIC INFARCT. COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2012 NOTED NO ABNORMALITIES. THE PATIENT RECEIVED SPEECH THERAPY. NO OTHER TREATMENT WAS PROVIDED AND THE PATIENT'S SYMPTOMS RESOLVED ON (B)(6) 2012. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2012361

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention