BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1870598 · Received October 12, 2010

    Report

    Report Number
    3004742046-2010-00475
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OCCLUSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. 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. THE RX ACCULINK (1001344-30, (B)(4)) AND PROGLIDE (12673-03, UNK) ARE REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT AFTER RX ACCULINK STENT POST-DILATATION IN THE RIGHT INTERNAL CAROTID ARTERY, NO FLOW OCCURRED. NITROGLYCERIN WAS GIVEN AND THE EMBOSHIELD NAV 6 FILTER BASKET WAS RETRIEVED; VIGOROUS FLOW WAS RESTORED. POST PROCEDURE, THE PATIENT EXPERIENCED A STROKE WITH BLURRED AND DOUBLE VISION. MRI SHOWED NUMEROUS TINY ACUTE LACUNAR INFARCTS, THE MAJORITY OF WHICH WERE ON THE RIGHT. PLAVIX AND COUMADIN WERE STARTED AND HOSPITALIZATION WAS PROLONGED. IN THE PHYSICIAN'S OPINION, THE BILATERAL CEREBRAL INFARCTS WERE RELATED TO A HISTORY OF CHRONIC ATRIAL FIBRILLATION. POST PROCEDURE, ASYMPTOMATIC BRADYCARDIA AND HYPOTENSION OCCURRED THAT PERSISTED MORE THAN 48 HOURS AND WAS TREATED WITH NEO-SYNEPHRINE FOR ABOUT 2 DAYS, FOLLOWED BY PSEUDOEPHEDRINE. ON (B)(6) 2010, AT TIME OF DISCHARGE, ANTI-HYPERTENSIVE MEDICATIONS WERE HELD. HYPOTENSION AND BRADYCARDIA HAD RESOLVED. AT A FOLLOW-UP VISIT, ON (B)(6) 2010, THE MINOR DIPLOPIA WAS IMPROVING. 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 0042651

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R| S VIATRAC 5.5 X 20 X 135| RX ACCULINK (1001344-30, 8112551)| HEPARIN, PROGLIDE (12673-03, UNK)