BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2424071 · Received January 20, 2012

    Report

    Report Number
    1058196-2012-00029
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    February 21, 2011
    Report Date
    December 29, 2011
    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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ROADMASTER/GOODMAN, 606-S255X(LOT#UNKNOWN), EXCELSIOR SL10/STRYKER, ECHELON/EV3, RADIFOCUS GT/TERUMO, TRUFILL DCS ORBIT 4X7(LOT# UNKNOWN), TRUFILL DCS ORBIT 3.5X5(LOT# UNKNOWN), GDC/STRYKER(TOTAL), ED/KANEKA(TOTAL). THE ORBIT COILS REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT AVAILABLE; THEREFORE, THE DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. ANEURYSM RECANALIZATION AFTER COIL EMBOLIZATION IS A KNOWN POTENTIAL 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. WITH REVIEW OF THE LIMITED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2012-00028 AND 1058196-2012-00029.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE (B)(4) POST MARKET STUDY THAT APPROXIMATELY SIX MONTHS POST STENT ASSISTED COIL EMBOLIZATION THERE WAS RECANALIZATION OF THE ANEURYSM. AT INDEX PROCEDURE, THE COILS IMPLANTED INCLUDED A 4X7 TRUFILL DCS ORBIT MINI COMPLEX FILL (637MF0407), A 3.5X5 TRUFILL DCS MINI COMPLEX FILL (637MF3505), GDC/STRYKER, AND ED/KANEKA. IT WAS FURTHER REPORTED THAT THE ACTION TAKEN WAS ADMINISTRATION OF CILOSTAZOL 100MG/DAY WITHOUT ANY FURTHER COIL PLACEMENT. SIX MONTHS LATER, ONE YEAR POST INDEX PROCEDURE, THE EVENT WAS "ONGOING/UNCHANGED" WITH AN ANEURYSM NECK OF 7.6MM AND NECK TO SAC RATIO OF 7.5MM:6.5MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 5.5MM AND DISTALLY WAS 4.5MM. THIS IS GREATER THAN THE MAXIMUM VESSEL DIAMETER RECOMMENDED FOR USE OF THE ENTERPRISE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THE MODIFIED RANKIN SCORE (MRS) WAS 0. THE OCCLUSION RATE OF ANEURYSM WAS LESS THAN 95%. NO FURTHER COIL EMBOLIZATION WAS PERFORMED. THE PHYSICIAN REPORTED THAT THE POSSIBLE CAUSE OF THE EVENT WAS COIL COMPACTION. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND WAS UNRELATED TO THE ENTERPRISE VRD. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE.

    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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R