BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC KIT

    MDR report key: 3231131 · Received July 17, 2013

    Report

    Report Number
    1058196-2013-00188
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 10, 2010
    Report Date
    June 25, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KGG
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND THERE WAS NO STERILE LOT NUMBER INFORMATION REPORTED THUS NO DHR MAYBE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    MARINE, L., ET AL ¿GLUE EMBOLUS COMPLICATING THE ENDOVASCULAR TREATMENT OF A PATIENT WITH LOEYS-DIETZ SYNDROME¿, J.VASCSURG 2010;52:1350-3 REPORT THAT NBCA GLUE EMBOLIZED TO THE BRACHIAL ARTERY DURING OFF LABEL USE OF NBCA GLUE TO FILL A SUBCLAVIAN PSEUDOANEURYSM WHILE USING AN OPTA ANGIOPLASTY TO COVER THE NECK. A VEIN BYPASS WAS REQUIRED AND THE PATIENT WAS DISCHARGED ASYMPTOMATIC WITH A PALPABLE RADIAL PULSE. THE PATIENT WAS DIAGNOSED WITH LOEYS-DIETZ SYNDROME AND PRESENTED WITH A SYMPTOMATIC 2.6 CM SUBCLAVIAN PSEUDOANEURYSM. EXTENSIVE STAGED COIL EMBOLIZATION OF PROXIMAL LEFT SUBCLAVIAN BRANCHES INCLUDING THE VERTEBRAL, INTERNAL MAMMARY, AND THYROCERVICAL TRUNK ARTERIES WAS ALSO REQUIRED TO INSURE AGAINST PSEUDOANEURYSM ENLARGEMENT OR RUPTURE SECONDARY TO A TYPE II ENDOLEAK. CATHETER DIRECTED NBCA SAC EMBOLIZATION WAS DONE FOR COMPLETE ABLATION OF THE PSEUDOANEURYSM SAC AND ANY REMNANT SMALL BRANCHES. AN 8MMX4CM OPTA BALLOON ANGIOPLASTY CATHETER WAS INFLATED TO COVER THE NECK OF THE ANEURYSM DURING NBCA EMBOLIZATION. THE GLUE WAS DILUTED 1:1 AND INSTILLED VIA A COAXIAL MC WITH A TOTAL OF 1.5ML INSTILLED. DURING DEFLATION OF THE BALLOON, A SMALL AMOUNT OF GLUE DEBRIS WAS NOTED GOING DOWN THE SUBCLAVIAN ARTERY TO THE BRACHIAL ARTERY. THE BRACHIAL ARTERY WAS IMMEDIATELY CLAMPED WITH SHEATH REMOVAL AND A 10MMX5CM VIABAHN STENT GRAFT WAS DEPLOYED EXCLUDING THE LEFT SUBCLAVIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330895 NBCA LIQUID EMBOLIC KIT CNV_NBCA (MFE) KGG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening 8MMX4CM OPTA BALLOON, UNK MICROCATHETER