BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 3211292 · Received July 8, 2013

    Report

    Report Number
    1058196-2013-00178
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2012
    Report Date
    June 18, 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

    ANEURYSM RECANALIZATION/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/COIL COMPACTION POST COIL EMBOLIZATION INCLUDE NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. THE LOT NUMBERS OF THE COILS USED AT INDEX PROCEDURE PRIOR TO THE REPORTED ANEURYSM RECANALIZATION/COIL COMPACTION ARE NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AND NO CORRECTIVE ACTIONS WILL BE TAKEN. ALL THE COILS REMAIN IMPLANTED. MICROCOIL SELECTION IS AT THE DISCRETION OF THE PHYSICIAN AND IS CHOSEN BASED UPON PRE-EMBOLIZATION ANGIOGRAPHIC ASSESSMENT OF THE DIAMETER, HEIGHT, WIDTH OF THE ANEURYSM AS WELL AS THE WIDTH OF THE ANEURYSM OSTIUM. WITH REVIEW OF THE AVAILABLE INFORMATION TARGET SITE CHARACTERISTICS, AND DEVICE SIZE SELECTION ARE FACTORS CONTRIBUTING TO THE REPORTED EVENTS. THERE ARE NO INDICATIONS OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS FOR 3 ORBIT MINI COMPLEX FILL COILS, AND ALSO IS FOR (B)(4).

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH (B)(6) INDICATED THAT THIRTEEN MONTHS AFTER THE INDEX PROCEDURE OF AN ANEURYSM OF THE BA-TIP WITH AN ENTERPRISE VRD (ENC452812/01424296) AND CODMAN COILS AND NON-CODMAN COILS (PRESIDIO MICROCOIL (PC410073030/LOT UNK X2, ORBIT COILS (638CF0824/LOT UNK X3, 638CF0721/LOT UNK X3, 638CF0615/LOT UNK, 638CF0515/LOT UNK, 638CF0510/LOT UNK, 637MF0410/LOT UNK X3, ORBIT GALAXY COILS (640CX0408/LOT UNK X4, 640CX0306/LOT UNK X4, 640CX0304/LOT UNK X2), & ED COILS INFINITY (16MM X 30CM, 16MM X 20CM TOTAL 3)/KANEKA), MRI REVEALED SLIGHT BLOOD FLOW TO THE TREATED ANEURYSM NECK, BUT ANEURYSM GROWTH WAS NOT CONFIRMED. TWO YEARS AFTER THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT DEVELOPED FORGETFULNESS AND GAIT DISORDER THAT WAS ATTRIBUTED TO THE ALZHEIMER'S DISEASE AT PSYCHIATRY, THE PHYSICIAN CONSIDERED THAT IT WAS UNRELATED TO THE TREATED ANEURYSM. TWENTY SIX MONTHS POST PROCEDURE, MRA REVEALED A RECANALIZATION OF THE TREATED ANEURYSM DUE TO COIL COMPACTION. NO ACTION WAS TAKEN. THE EVENT OUTCOME AS OF DATE OF ONSET WAS ONGOING/UNCHANGED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED, BECAUSE MORE THAN 2 YEARS HAD ELAPSED AFTER THE INDEX PROCEDURE. PRIOR TO IMPLANTING THE VRD, ENVOY(556-258-90, LOT UNKNOWN), AXCELGUIDE 3FR 95CM/MEDIKIT, PROWLER SELECT PLUS(606-S255X, LOT UNKNOWN), CHIKAI 200CM 0.014INCH/ASAHI INTECC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE ECHELON 14(TYPE 45 DEGREES)/COVIDIEN JAPAN, PRESIDIO MICROCOIL (PC410073030/LOT UNK X2), ORBIT COILS (638CF0824/LOT UNK X3, 638CF0721/LOT UNK X3, 638CF0615/LOT UNK, 638CF0515/LOT UNK, 638CF0510/LOT UNK, 637MF0410/LOT UNK X3), ORBIT GALAXY COIL (640CX0408/LOT UNK X4, 640CX0306/LOT UNK X4, 640CX0304/LOT UNK X2), ED COILS INFINITY (16MM X 30CM, 16MM X 20CM TOTAL 3)/KANEKA. DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311557 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening