BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1645700 · Received March 12, 2010

    Report

    Report Number
    3004742046-2010-00096
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE RX ACCULINK (1011343-40, 9011251) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE ISSUE: BARE WIRE, BALLOON ENTANGLEMENT. TIME OF DEVICE ISSUE: DURING THE INTERVENTIONAL PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT ON (B)(6)2010, APPROXIMATELY 6 MONTHS POST RX ACCULINK STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY (LICA), ASYMPTOMATIC RESTENOSIS OCCURRED. DURING AN INTERVENTIONAL PROCEDURE TO TREAT THE RESTENOSIS, ON (B)(6)2010, AN EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS POSITIONED WITH DIFFICULTY DUE TO VESSEL TORTUOSITY AND HEAVY LESION CALCIFICATION, HOWEVER, IT COULD NOT BE DEPLOYED. THE SHEATH DID NOT RETRACT AS THE HANDLE WAS PULLED BACK. THE EPD WAS REMOVED. A SECOND EMBOSHIELD NAV6 WAS SUCCESSFULLY DEPLOYED AND THE LESION WAS PRE-DILATATED 7 TIMES. AN XACT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE TARGET LESION. A NON-ABBOTT CUTTING BALLOON COULD NOT CROSS THE LESION; HOWEVER, A NON-ABBOTT BALLOON CATHETER CROSSED. THE LESION WAS DILATATED WITH THIS BALLOON AND THE STENOSIS WAS REDUCED FROM 80% TO 30%. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY AND 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 9051651

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR OTHER: BIVALIRUDIN| ATHERECTOMY: BOSTON SCIENTIFIC CUTTING BALLOON| GUIDE WIRE: SUPRACORE| STENT: RX ACCULINK (1011343-40, 9011251)| INFLATION: ENCORE ADVANTAGE| ANGIOSCULPT| SHEATH: TERUMO CAROTID ST| UNIVERSAL II| DIL CATH: VOYAGER RX