BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2964066 · Received February 15, 2013

    Report

    Report Number
    1058196-2013-00041
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    September 10, 2012
    Report Date
    January 23, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS UTILIZED DURING THE PROCEDURE CONSISTED OF PROWLER SELECT PLUS MICROCATHETER (MC), SHUTTLE SHEATH MICROCATHETER, EXCELSIOR, ECHELON GW, CHIKAI GT WIRE, ORBIT COILS (638CF0721/LOT 16147547 X 4 UNITS), MICRO PLEX, PRESISIO, AND HYDRO COIL. THE UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT CAVERNOUS SINUS NECK MEASURED 10.4MM AND THE NECK TO SAC RATIO WAS 10.4/22.8MM, AND THE PARENT VESSEL PROXIMAL DIAMETER WAS 5.2MM AND THE DISTAL WAS 3.9MM. MEDICATIONS CONSISTED OF ASPIRIN 100MG/DAY (DATE UNKNOWN) AND PLAVIX 75MG/DAY (10/8/2010-). A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. THE LOT NUMBERS OF THE IMPLANTED COILS ARE NOT KNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEWS CANNOT BE COMPLETED. COIL COMPACTION 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 NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. PROCEDURAL FACTORS AND VESSEL/ANEURYSM CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED ANEURYSM RE-CANALIZATION DUE TO COIL COMPACTION. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIOGRAM PERFORMED DURING THE 2-YEAR FOLLOW UP REVEALED RECANALIZATION OF THE ANEURYSM DUE TO COIL COMPACTION WITH 4 ORBIT COILS (638CF0721/LOT UNK). THE OCCLUSION RATE OF ANEURYSM WAS 60%. THE MRS WAS 1. ACTION TAKEN WAS AN ADDITIONAL COIL EMBOLIZATION. THE EVENT OUTCOME AS OF A MONTH AFTER ONSET RESOLVED WITHOUT SEQUEL. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED. THE MRS AT 1 AND 2 YEAR FOLLOW-UP WAS 1. IN THE 2 YEAR FOLLOW-UP IT WAS NOTED THAT THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.2MM, AND THE NECK TO SAC RATIO WAS 4.2MM:8.3MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.2MM AND DISTALLY WAS 2.3MM. ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 75MG/DAY, AND ARGATROBAN HYDRATE 40MG/DAY. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66210 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention