BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 3018397 · Received March 22, 2013

    Report

    Report Number
    1058196-2013-00077
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO IMPLANTING THE VRD, A JAILED TECHNIQUE WAS UTILIZED. THE FOLLOWING PRODUCTS WERE UTILIZED AN AXCEL GUIDE 5FR 95CM (MEDIKIT), PROWLER SELECT PLUS MICROCATHETER (606-S255X, LOT UNKNOWN), CHIKAI GUIDEWIRE (ASAHI INTECC). OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE AN ECHELON 14MICROCATHETER (TYPE 45 DEGREES) COVIDIEN (B)(4), EXCELSIOR 1018 MICROCATHETER (TYPE 90 DEGREES)/STRYKER, TRANSEND EX/STRYKER, GDC 18 COILS (12MM X 30CM TOTAL2, 10MM X 30CM TOTAL 2)/STRYKER, V-TRACK MICROPLEX COMPASS COILS (10MM X 30CM, 8MM X 25CM TOTAL 2)/TERUMO, ORBIT COILS (638CF0615 TOTAL 5). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE PATIENT MEDICAL HISTORY CONSISTED OF SUBARACHNOID HEMORRHAGE ((B)(6) 2009), OSTEOPOROSIS AND PREVIOUS COIL EMBOLISATION FOR LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE RUPTURED SACCULAR ANEURYSM NECK WAS 13.1MM, AND THE NECK TO SAC RATIO WAS 13.1MM:16.2MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.1MM AND DISTALLY WAS 3.0MM. THE MRS BEFORE THE PROCEDURE ON (B)(6) 2011 WAS 3, AFTER THE PROCEDURE ON (B)(6) 2011 WAS 3 AND ON (B)(6) 2011 WAS 3. THE ACT WAS 146 SECONDS PRE ANTICOAGULATION AND 376 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE PROCEDURE. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 75MG/DAY, CILOSTAZOL 100MG, AND HEPARIN 4000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE ORBIT COILS REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT AVAILABLE; THEREFORE, THE DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. SUBARACHNOID HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF COILS, AND THE INHERENT RISK OF INTRODUCING DEVICES INTO THE DELICATE CEREBRAL VESSELS AS WELL AS THE CHANGES IN INTRACRANIAL PRESSURES AND ANATOMY POST COIL PLACEMENT WITHIN THE ANEURYSM CAN CONTRIBUTE TO THE OCCURRENCE OF INTRACRANIAL AND ANEURISMAL BLEEDING COMPLICATIONS. COIL EMBOLIZATION PATIENTS ARE STARTED AND MAINTAINED ON ANTICOAGULANT AND ANTI-PLATELET MEDICATION REGIMENS THAT CAN CONTRIBUTE TO THE LIKELY HOOD OF BLEEDING IN THE PERI AND POST OPERATIVE PHASES. ADDITIONALLY, 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.

    Description of Event or Problem · 1

    THE REPORT FROM THE CLINICAL STUDY (B)(4) PMS ENTERPRISE FOR PATIENT WITH ID#203-07 INDICATED THAT THE PATIENT WAS HOSPITALIZED A YEAR AFTER THE INDEX PROCEDURE WITH SUBARACHNOID HEMORRHAGE FROM THE TREATED ANEURYSM (LEFT POSTERIOR COMMUNICATING ARTERY) WITH 5 ORBIT COILS (638CF0615/LOT UNK) AND NON-CODMAN COILS, AND A MONTH AFTER THE SUBARACHNOID HEMORRHAGE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. SUBSEQUENTLY, HAD DISTURBANCE OF CONSCIOUSNESS AND THE PATIENT'S GENERAL CONDITION DETERIORATED, AND DESPITE THE TREATMENTS, THE PATIENT EXPIRED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNRELATED. THE PHYSICIAN THOUGHT THE EVENT MIGHT HAVE BEEN CAUSED BY THE INCOMPLETE EMBOLISATION OF THE TREATED ANEURYSM. DURING THE SUBARACHNOID EVENT, AN URGENT HEAD COMPUTED TOMOGRAPHY SCAN REVEALED RECANALIZATION OF THE TREATED ANEURYSM DUE TO COIL COMPACTION. THE PATIENT WAS AN ADVANCED AGE AND HUNT AND KOS NIK GRADE WAS 5, THEREFORE, THE ADDITIONAL COIL EMBOLIZATION WAS NOT PERFORMED IN PHYSICIAN'S JUDGMENT. THE CONSERVATIVE THERAPY INVOLVED IN ANTIHYPERTENSIVE TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119617 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| L