BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1884464 · Received October 19, 2010

    Report

    Report Number
    3004742046-2010-00492
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 24, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH THE PREVIOUSLY IMPLANTED STENTS, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT IS LIKELY THAT THE ANATOMICAL CONDITIONS CONTRIBUTED TO BOTH THE DIFFICULTY TO ADVANCE THE DELIVERY CATHETER AND RETRIEVAL CATHETER. ADDITIONALLY, IT IS POSSIBLE THAT THE ATTEMPTS TO CROSS THE IMPLANTED STENTS CONTRIBUTED TO THE REPORTED RESISTANCE DURING RETRIEVAL CATHETER ADVANCEMENT. THE REPORTED COMPLAINT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE RX ACCULINK IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 TARGET LESIONS WERE TREATED, THE LEFT INTERNAL CAROTID ARTERY (LICA) AND THE LEFT COMMON CAROTID ARTERY (LCCA). A TYPE 2 BOVINE AORTIC ARCH AND 80% COMMON CAROTID STENOSIS RESULTED IN DIFFICULTY ADVANCING DEVICES, REQUIRING BUDDY WIRES. THE PT WAS REPORTEDLY UNCOOPERATIVE AND THERE WAS PT MOVEMENT DURING THE PROCEDURE RESULTING IN POOR ANGIOGRAPHIC IMAGING. ALTHOUGH RESISTANCE WAS MET ADVANCING THE EMBOSHIELD NAV 6 THROUGH THE LICA THE FILTER WAS POSITIONED USING A BUDDY WIRE. RESISTANCE WAS MET ADVANCING AN RX ACCULINK STENT DELIVERY SYS (SDS). USING A BUDDY WIRE THE SDS WAS POSITIONED IN THE LICA LESION AND THE STENT WAS DEPLOYED WITHOUT DIFFICULTY. A DISSECTION WAS THEN SEEN DISTAL TO THE STENT; BLOOD FLOW WAS REASONABLY GOOD SO IT WAS DECIDED TO TREAT THE LCCA. AN XACT STENT WAS DEPLOYED IN THE LCCA WITHOUT DIFFICULTY; HOWEVER, VERY POOR FLOW OCCURRED IN THE LICA, ASSOCIATED WITH THE PT DEVELOPING DECREASED AWARENESS. THE POOR FLOW WAS BELIEVED TO BE DUE TO THE DISSECTION, THEREFORE, A SECOND ACCULINK STENT (6X30) WAS IMPLANTED, IN THE LICA, USING A BUDDY WIRE TO COVER THE DISSECTION. THERE WAS DIFFICULTY ADVANCING THE EMBOSHIELD NAV 6 RECOVERY CATHETER (RC) TO RETRIEVE THE FILTER. ONCE A BUDDY WIRE WAS PLACED THE RC ADVANCED AND CAPTURED THE FILTER. BLOOD FLOW IMPROVED AFTER FILTER REMOVAL AND THE PT'S NEUROLOGIC STATUS RETURNED TO BASELINE. ON (B)(6) 2010: CAROTID ULTRASOUND SHOWED LCCA AND LICA STENTING WITH PRESERVATION OF FLOW. ON (B)(6) 2010, 16 DAYS POST PROCEDURE, THE PT WAS HOSPITALIZED WITH APHASIA, RIGHT HEMIPARESIS AND EXTREMELY HIGH BLOOD PRESSURE. CT OF THE HEAD SHOWED LEFT MIDDLE CEREBRAL ARTERY HEMORRHAGIC INFARCT AND LEFT PARIETAL PARENCHYMAL HEMORRHAGE. LABORATORY RESULTS SHOWED A PTT OF 32 SEC (NORMAL RANGE 23-31) AND PT OF 14.8 SEC (NORMAL RANGE 12.2-14.5). THE PT WAS DISCHARGED TO A SKILLED NURSING FACILITY ON (B)(6) 2010. ON (B)(6) 2010, THE PT WAS READMITTED WITH PNEUMONIA, HYPOXIA, AND ALTERED MENTAL STATUS. TRACHEAL ASPIRATE CULTURE GREW ENTEROBACTER AEROGENES. FLUOROSCOPY REVEALED A PREVIOUSLY PLACED PERCUTANEOUS GASTROSTOMY TUBE WAS CLOGGED AND IT WAS, THEREFORE, REPLACED WITH A NEW TUBE. CT SCAN OF THE HEAD SHOWED SLIGHT INTERVAL EVOLUTION OF FRONTAL PARIETAL INTRAPARENCHYMAL HEMORRHAGE SINCE (B)(6) 2010. PNEUMONIA IMPROVED WITH ANTIBIOTICS. THOUGH REQUESTED NO ADDITIONAL INFO 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 0071451

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PLAVIX| COUMADIN| SHEATH: 6 FR| STENT: XACT (PART 82098-01, LOT 9110451)| STENT: RX ACCULINK (1011344-40, 0062961)| ASPIRIN| HEPARIN