BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1834025 · Received September 14, 2010

    Report

    Report Number
    1058196-2010-00266
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    October 30, 2010
    Report Date
    August 18, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    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 (50-75 IU/KG BODY WEIGHT), 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE AMERICAN JOURNAL OF NEURORADIOLOGY 26: 1342-1348, JUNE/JULY 2005 "THREE-DIMENSIONAL PACKING FOR COMPLEX ORBIT COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSM", LUBICZ ET AL., A (B)(6) MALE (PATIENT 6) PRESENTED WITH SUBARACHNOID HEMORRHAGE (SAH) AND A 5MM ANEURYSM WAS FOUND IN THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. AFTER PLACEMENT OF AN ORBIT 5X15CM AND 3X4CM, THE LAST COIL, A 2MMX1.5CM COMPLEX ORBIT COIL COULD NOT BE DELIVERED BECAUSE OF ITS STIFFNESS AND A 2MMX2CM HELICAL COIL WAS PLACED INSTEAD TO OCCLUDE THE ANEURYSM NECK. THE COILS WERE DELIVERED VIA A NONCORDIS EXCELSIOR 10 MICROCATHETER. SYSTEMIC HEPARINIZATION WAS ADMINISTERED DURING THE PROCEDURE WITH MONITORING OF ADEQUACY OF ANTICOAGULATION BY FREQUENT MEASUREMENTS OF THE ACTIVATED CLOTTING TIME (ACT). A BASELINE ACT WAS OBTAINED BEFORE THE BOLUS INFUSION OF HEPARIN (50-75 IU/KG BODY WEIGHT), 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. THERE IS NO FURTHER PROCEDURAL INFORMATION AVAILABLE. THE COIL IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. IT IS POSSIBLE THAT PROCEDURAL FACTORS, VESSEL/ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE EVENT; HOWEVER, BASED ON THE LACK OF CLINICAL INFORMATION NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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" INDICATED THAT 6 PRESENTED WITH (SAH) SUBARACHNOID HEMORRHAGE AND A 5MM ANEURYSM WAS FOUND IN THE (MCA) MIDDLE CEREBRAL ARTERY BIFURCATION. A 2MM / 1.5CM COMPLEX COIL COULD NOT BE DELIVERED BECAUSE OF ITS STIFFNESS AND A 2MM/2 CM HELICAL COIL WAS PLACED INSTEAD TO OCCLUDE THE ANEURYSM NECK.

    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 54 YR EXCELSIOR 10 MICROCATHETER