BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1905850 · Received November 23, 2010

    Report

    Report Number
    3004742046-2010-00552
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THE REPORTED HOSPITALIZATION WAS IN RESPONSE TO THE PATIENT SYMPTOMS. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, 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 THAT DURING THE PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT (CVA) WITH LEFT SIDED WEAKNESS AND INATTENTION, SENSORY LOSS, HEMIANOPIA, APHASIA AND DYSARTHRIA. CT SCAN REVEALED EVOLVING RIGHT MIDDLE CEREBRAL ARTERY CVA. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2010. THE NEUROLOGIC SYMPTOMS IMPROVED ALTHOUGH DEFICITS CONTINUE. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA 0081951

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S