BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1858974 · Received October 5, 2010

    Report

    Report Number
    3004742046-2010-00461
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE RX ACCUNET (P.N. 1011649-55, LOT # 9110551) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. EVALUATION SUMMARY: FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH THE PREVIOUSLY IMPLANTED STENTS, AND ACCESSORY DEVICE SUPPORT. REPORTEDLY, THE TARGET LESION WAS HEAVILY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE DURING ADVANCEMENT OF THE DELIVERY CATHETER. REPORTEDLY, POST PROCEDURE THE PATIENT EXPERIENCED NEUROLOGICAL DEFICIT/DYSFUNCTION AND THE PATIENT WAS HOSPITALIZED. THE EMBOSHIELD NAV 6 INSTRUCTIONS FOR USE, LISTS NEUROLOGICAL DEFICIT/DYSFUNCTION AS A KNOWN ADVERSE PATIENT EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THE REPORTED FAILURE TO ADVANCE AND NEUROLOGICAL EVENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE LOT HISTORY RECORD FOUND NOTHING RELEVANT TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT CRITICAL STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY (LICA), AN EMBOSHIELD NAV6 AND AN RX ACCUNET WERE UNABLE TO CROSS THE SEVERELY TORTUOUS, S-SHAPED LICA AND THE INTERVENTIONAL PROCEDURE WAS ABANDONED. HOWEVER, 4 HOURS POST THE ATTEMPTED PTI PROCEDURE THE PATIENT EXPERIENCED RIGHT HEMIPLEGIA AND DYSARTHRIA. HOSPITALIZATION WAS PROLONGED. ALTHOUGH CT SCAN OF THE HEAD, DONE ON (B)(6) 2010, SHOWED POSSIBLE STROKE, MRIS, DONE ON (B)(6) 2010 AND (B)(6) 2010 SHOWED NO ACUTE ABNORMALITY AND STROKE WAS RULED OUT. THE NEUROLOGIC DEFICITS RESOLVED 2 DAYS LATER AND THE EVENT WAS DIAGNOSED AS TRANSIENT ISCHEMIC ATTACK. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0040651

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| S