BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1833844 · Received September 14, 2010

    Report

    Report Number
    1058196-2010-00264
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    October 30, 2004
    Report Date
    August 18, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT AFTER FURTHER REVIEW OF THIS ARTICLE LUBICZ ET AL IN AM J NEURADIOL 26: 1342-1348 REPORT IN "THREE-DIMENSIONAL PACKING FOR COMPLEX ORBIT COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSM" THERE WERE NO ADVERSE EVENTS OR PRODUCT MALFUNCTIONS ASSOCIATED TO PATIENT #4. THEREFORE, NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS PATIENT, SINCE THERE NO EVENTS THAT MEET THE CRITERIA FOR REPORTING. . THIS ONE OF FOUR PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00263, 1058196-2010-00264 AND 1058196-2010-00265.

    Additional Manufacturer Narrative · 1

    IN ALL PATIENTS, THE ENDOVASCULAR TREATMENT WAS PERFORMED UNDER GENERAL ANESTHESIA AND SYSTEMIC HEPARINIZATION. THE ADEQUACY OF SYSTEMIC ANTICOAGULATION WAS MONITORED BY FREQUENT MEASUREMENTS OF THE ACTIVATED CLOTTING TIME (ACT). A BASELINE ACT WAS OBTAINED BEFORE THE BOLUS INFUSION OF HEPARIN (B)(6), AND HOURLY THEREAFTER. THE BOLUS INFUSION OF HEPARIN WAS FOLLOWED BY A CONTINUOUS DRIP (1,000 ,1,500 IU/H), WITH THE PURPOSE OF DOUBLING THE BASELINE ACT. IN MOST PATIENTS, SYSTEMIC HEPARINIZATION WAS STOPPED AT THE END OF THE PROCEDURE. FOR WIDE-NECK ANEURYSMS OR IN CASES WITH PERIPROCEDURAL COMPLICATIONS, SYSTEMIC HEPARINIZATION WAS PROLONGED FOR 48,72 HOURS. PATIENTS WERE TREATED BY SELECTIVE EMBOLIZATION WITH ORBIT COILS; WE HAVE TRIED TO OBTAIN A 3D PACKING OF THE ANEURYSMS BY FORMING A BASKET WITH A COMPLEX COIL THAT WAS SUBSEQUENTLY FILLED CONCENTRICALLY WITH SMALLER COMPLEX COILS IN AN "ONION-LIKE" FASHION. AN EXCELSIOR 10 MICROCATHETER (B)(4) WAS USED TO DELIVER COILS WITHIN THE ANEURYSM. AFTER ENDOVASCULAR TREATMENT, PATIENTS WERE TRANSFERRED TO THE INTENSIVE CARE UNIT, AND FLUID BALANCE, NEUROLOGIC STATUS, AND BLOOD PRESSURE WERE CAREFULLY MONITORED. FOLLOW-UP MRA AT 6 MONTHS WERE OBTAINED IN ALL 16 PATIENTS AND SHOWED 14 COMPLETE OCCLUSIONS, ONE NECK REMNANT, AND ONLY ONE SLIGHT RECANALIZATION. THIS ONE OF FOUR PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00263, 1058196-2010-00264 & 1058196-2010-00265. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    LUBICZ ET AL IN AM J NEURADIOL 26: 1342-1348 REPORT IN "THREE-DIMENSIONAL PACKING FOR COMPLEX ORBIT COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSM" THAT A (B)(6) FEMALE PATIENT (B)(4) PRESENTED WITH SAH AND AN ANEURYSM WAS FOUND IN THE MCA BIFURCATION THAT WAS TREATED WITH 3 COMPLEX COILS HAD RECANALIZATION 6 MONTHS AFTER THE PROCEDURE. IN THE INITIAL PROCEDURE, THE PATIENT WAS TREATED WITH 3 COMPLEX COILS (4MM/7CM, 3MM/3CM AND 2MM/2CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R EXCELSIOR 10 MICROCATHETER