BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1953223 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00160
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DILATATION CATHETER: VOYAGER; STENT: RX ACCULINK (1011344-30/UNK). (B)(4) - INCORRECT REMOVAL. THERE ARE SEVERAL POSSIBLE CAUSES FOR DIFFICULTY ADVANCING THE RETRIEVAL CATHETER (RC), INCLUDING, BUT NOT LIMITED TO, DAMAGE TO THE DELIVERY CATHETER, CHALLENGING ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY ADVANCING THE RETRIEVAL CATHETER IS DUE TO INTERACTION WITH THE NEWLY PLACED STENT. IT MAY BE POSSIBLE THAT THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL OR IMPLANTED IN AN ANGLED SEGMENT OF THE ARTERY RESULTING IN INTERACTION BETWEEN THE RETRIEVAL CATHETER AND THE STENT DURING ADVANCEMENT. DURING ATTEMPTED EMBOLIC PROTECTION DEVICE (EPD) REMOVAL, THE EMBOSHIELD NAV6 (RC) WAS UNABLE TO ADVANCE THROUGH THE DEPLOYED STENT DESPITE NECK MANEUVERS AND SHEATH ADVANCEMENT. IT WAS REPORTED THAT AN RX ACCUNET SHAPEABLE TIP RC WAS USED IN AN ATTEMPT TO RECOVER THE EPD; HOWEVER, IT COULD ONLY BE ADVANCED PARTIALLY THROUGH THE STENT; THEREFORE, THE EPD WAS PULLED DOWN INTO THE ACCUNET RC AND WAS REMOVED FROM THE BODY. THE EMBOSHIELD NAV 6 INSTRUCTION FOR USE (IFU) INSTRUCTS TO: ADVANCE THE RX RETRIEVAL CATHETER SO THAT ITS TIP OPPOSES THE PROXIMAL PORTION OF THE FILTRATION ELEMENT AND GENTLY PUSH THE FILTRATION ELEMENT DISTALLY UNTIL IT IS SITUATED IN AN UNSTENTED PORTION OF VESSEL. RETRIEVAL CAN THEN PROCEED. IN THIS CASE, PULLING THE FILTRATION ELEMENT THROUGH THE STENTED SEGMENT DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED RETRIEVAL DIFFICULTIES. WITHOUT HAVING THE PRODUCT FOR EVALUATION, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY ADVANCING THE RETRIEVAL CATHETER COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE RX ACCUNET (1011649-65/0101361) AND THE RX ACCULINK (1011344-30/UNK) ARE EACH BEING FILED UNDER SEPARATE MFRS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE (EPD) WAS SUCCESSFULLY POSITIONED IN THE LEFT INTERNAL CAROTID ARTERY. THE TARGET LESION WAS IN THE LEFT COMMON AND INTERNAL CAROTID ARTERIES. DURING ACCULINK STENT DEPLOYMENT, THE STENT MIGRATED FORWARD AND WAS IMPLANTED COMPLETELY IN THE TARGET INTERNAL CAROTID ARTERY. ALTHOUGH THE COMMON CAROTID WAS NOT COVERED, NO INTERVENTION WAS PERFORMED. THE STENT WAS POSTDILATED AND THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. NEOSYNEPHRINE WAS GIVEN AND BOTH RESOLVED THE SAME DAY. DURING ATTEMPTED EPD REMOVAL, THE NAV6 RETRIEVAL CATHETER (RC) WAS UNABLE TO ADVANCE THROUGH THE DEPLOYED STENT DESPITE NECK MANEUVERS AND SHEATH ADVANCEMENT. AN RX ACCUNET SHAPEABLE TIP RC COULD ONLY BE ADVANCED PARTIALLY THROUGH THE STENT; THEREFORE, THE EPD WAS PULLED DOWN INTO THE ACCUNET RC AND WAS REMOVED FROM THE BODY. 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 EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention