BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1833571 · Received September 14, 2010

    Report

    Report Number
    1058196-2010-00262
    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

    AS REPORTED IN THE AMERICAN JOURNAL OF NEURORADIOLOGY 26:1342-1348, JUNE/JULY 2005, IN "THREE-DIMENSIONAL PACKING WITH COMPLEX ORBIT COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS", SIX MONTHS POST COIL EMBOLIZATION OF A LEFT BIFURCATION ANEURYSM USING TRUFILL DCS ORBIT COILS, MRA SHOWED A SLIGHT RECANALIZATION OF THE ANEURYSM NECK. AT INDEX PROCEDURE, THE (B)(6) FEMALE (PATIENT 10) WHO PRESENTED WITH CHRONIC HEADACHES UNDERWENT BRAIN IMAGING AND COILING OF AN UNRUPTURED 7MM LEFT INTERNAL CAROTID ARTERY BIFURCATION ANEURYSM. SELECTIVE COILING WAS PERFORMED WITH FOUR COMPLEX COILS DELIVERED IN A CONCENTRIC FASHION, INCLUDING A 7 MMX21CM, 4 MMX7CM, 3 MMX4CM, AND A 2 MMX2CM COIL. THE COILS WERE DELIVERED VIA A NONCORDIS EXCELSIOR 10 MICROCATHETER. CONVENTIONAL ANGIOGRAM AT THE END OF THE EMBOLIZATION SHOWED A COMPLETE OCCLUSION. IT WAS INDICATED THAT THE IMMEDIATE CLINICAL OUTCOME WAS EXCELLENT. 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 OR FOLLOW-UP INFORMATION AVAILABLE. THE LOT NUMBERS OF THE TRUFILL DCS ORBIT COILS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW IS NOT POSSIBLE. ANEURYSM RECANALIZATION AFTER COIL EMBOLIZATION IS A KNOWN EVENT AND HAS BEEN ESTIMATED TO OCCUR IN ANYWHERE FROM 5% TO 38% OF COILED ANEURYSMS. FACTORS WHICH MAY HAVE A CORRELATION WITH RECANALIZATION POST COIL EMBOLIZATION INCLUDE LARGER ANEURYSM SIZE, NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. BASED ON THE AVAILABLE INFORMATION AND IMAGES IN THE ARTICLE, ANEURYSM LOCATION AND CHARACTERISTICS/SIZE ARE POSSIBLE CONTRIBUTING FACTORS. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF FOUR PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00259, 1058196-2010-00260, 1058196-2010-00261 AND 1058196-2010-00262.

    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 (TARGET THERAPEUTICS, (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 1058196-2010-00259, 1058196-2010-00260, 1058196-2010-00261 & 1058196-2010-00262. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED IN THE AM J NEURORADIOLOGY 26:1342,1348, JUNE/JULY 2005, IN "THREE-DIMENSIONAL PACKING WITH COMPLEX ORBIT COILS FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS", PATIENT 10 PRESENTED WITH CHRONIC HEADACHES UNDERWENT BRAIN IMAGING. AN UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM WAS DISCOVERED, AND THE PATIENT WAS REFERRED TO OUR DEPARTMENT FOR EMBOLIZATION. CONVENTIONAL ANGIOGRAPHY REVEALED A LEFT ICA BIFURCATION ANEURYSM. SELECTIVE COILING WAS PERFORMED WITH FOUR COMPLEX COILS DELIVERED IN A CONCENTRIC FASHION, INCLUDING A 7 MM/21 CM COIL A 4 MM/7 CM COIL, A 3 MM/4 CM COIL, AND A 2 MM/2 CM COIL. FINAL RESULT CONSISTED OF A COMPLETE OCCLUSION AND THE PATIENT WAS DISCHARGED 4 DAYS AFTER THE TREATMENT. MRA AT 6 MONTHS SHOWED A SLIGHT RECANALIZATION OF THE 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 44 YR Hospitalization| L| R EXCELSIOR 10 MICROCATHETER