BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3420626 · Received October 21, 2013

    Report

    Report Number
    2024168-2013-06685
    Event Type
    Injury
    Date Received
    October 21, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COLLAPSED FILTER WAS UNABLE TO BE CONFIRMED HOWEVER THE FILTER WAS TORN WHICH IS LIKELY THE ISSUE NOTED BY THE ACCOUNT. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE REPORTED PATIENT EFFECT OF TRANSIENT ISCHEMIC ATTACK (TIA) IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, NEW INFORMATION RECEIVED STATES THAT THE PATIENT SYMPTOMS OF TROUBLE SPEAKING AND RESTRICTED MOVEMENT OF HIS ARM AND LEG LASTED LONGER THAN 24 HOURS; HOWEVER, THE PATIENTS SYMPTOMS ARE NOW FULLY RESOLVED AND THE PATIENT WAS DISCHARGED TO HOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE INTERNAL CAROTID ARTERY THAT HAD NO CALCIFICATION PRESENT. THE NAV 6 DEVICE WAS PREPARED TO PUT INTO THE DELIVERY SYSTEM. THE DELIVERY SYSTEM PREPARATION WAS PERFORMED STEP BY STEP BY PULLING THE BAREWIRE TO LOAD THE FILTER INTO THE DELIVERY CATHETER WITHOUT ANY ISSUES NOTED. THE FILTER WAS SUCCESSFULLY DELIVERED AND RELEASED. AFTER INJECTION OF SOME CONTRAST MEDIUM TO SEE THE LOCATION OF THE FILTER IT WAS OBSERVED THAT THERE WAS SOMETHING WRONG WITH THE FILTER AND IT WAS THOUGHT THAT SOME CAROTID ARTERY PLAQUE COULD PASS THE FILTER; HOWEVER, AFTER THAT THE ACCULINK WAS DEPLOYED AND THE PROCEDURE ENDED SUCCESSFULLY. THE PATIENT EXPERIENCED A MINI STOKE POST PROCEDURE, HAD TROUBLE SPEAKING AND COULD NOT MOVE HIS LEG AND ARM AS NORMAL. THE PATIENT WAS TREATED WITH MEDICATIONS AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION. AFTER THE FILTER WAS RETRIEVED FROM THE RETRIEVAL CATHETER OUTSIDE THE PATIENT AND INSPECTED THERE WAS NO OBVIOUS DAMAGE TO THE FILTER. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR RETRACTION IN THE ARTERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. FOLLOW-UP INFORMATION REPORTS THAT 24 HOURS LATER THE PATIENT WAS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537860 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2011761

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention