BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2440916 · Received February 7, 2012

    Report

    Report Number
    1058196-2012-00077
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    February 23, 2011
    Report Date
    January 25, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE (B)(4) CLINICAL STUDY INDICATED THAT ONE DAY FOLLOWING A STENT ASSISTED COIL EMBOLIZATION OF A LEFT CAVERNOUS SINUS ANEURYSM WITH IMPLANTATION OF SEVENTEEN (17) ORBIT COILS, THE PATIENT DEVELOPED LEFT OCULOMOTOR PARALYSIS ASSOCIATED WITH ANEURYSM MASS EFFECT. BOTH MECOBALAMIN AND PREDNISOLONE WERE ADMINISTRATED FOR TREATMENT. THE EVENT OUTCOME, AS OF 7 MONTHS AFTER ONSET, WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNRELATED. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 9.1MM, AND THE NECK TO SAC RATIO WAS 9.1MM: 14.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.1MM. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY BEGINNING EIGHT DAYS PRE-PROCEDURE UP TO TWO WEEKS POST PROCEDURE. CILOSTAZOL 200MG/DAY WAS ADMINISTERED BEGINNING ONE WEEK PRE-PROCEDURE UNTIL FOUR DAYS POST PROCEDURE. ONGOING CLOPIDOGREL 75MG/DAY WAS STARTED EIGHT DAYS PRE-PROCEDURE. THE ACT WAS 161 SECONDS PRE ANTICOAGULATION AND 280 SECONDS POST ANTICOAGULATION. AN ENTERPRISE VRD WAS IMPLANTED IN THE PARENT VESSEL WITH A PROXIMAL VESSEL DIAMETER OF 3.5MM AND DISTAL DIAMETER OF 3.1MM. ORBIT COILS (638MF0410 / 15000037, 638MF0410/15209579 X2, 638CF0510/15218214, 638CF0510/15218215, 638CF0515/15157130 X2, 638CF0615/15146939, 638CF0615/15162188, 638CF0721/15184495 X 2, 638CF0824/15158719, 638CS1030/15229221, 638CS1230/15137037, 637MF0407/13471449, 637CF0510/15214384, AND 637CF0824/15153766) WERE IMPLANTED IN THE ANEURYSM. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13471449 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MASS EFFECT, THE COMPRESSION OF BRAIN STRUCTURES/CRANIAL NERVES, IS A KNOWN FACTOR CONTRIBUTING TO NEUROLOGICAL SYMPTOMS. THE POSITION OF THE OCULAR MOTOR NERVE WITHIN THE CAVERNOUS SINUS MAKES IT VULNERABLE TO COMPRESSIVE INJURY FROM THIS PATIENT'S LARGE CAVERNOUS ANEURYSM. NEUROLOGICAL DEFICITS AND INJURY TO VESSELS/TISSUE ARE KNOWN COMPLICATIONS SPECIFIC TO EMBOLIZATION PROCEDURES THAT MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES CONTRIBUTING TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2012-00064, 1058196-2012-00065, 1058196-2012-00066, 1058196-2012-00067, 1058196-2012-00068, 1058196-2012-00069, 1058196-2012-00070, 1058196-2012-00071, 1058196-2012-00072, 1058196-2012-00073, 1058196-2012-00074, 1058196-2012-00075, 1058196-2012-00076, AND 1058196-2012-00077.

    Additional Manufacturer Narrative · 1

    THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 9.1MM, AND THE NECK TO SAC RATIO WAS 9.1MM: 14.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.1MM. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY:2011 (B)(6), CLOPIDOGREL SULFATE 75MG/DAY: 2011 (B)(6), CILOSTAZOL 200MG/DAY:2011 (B)(6). NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, ENVOY 6.0FR/0.90IN(LOT# UNKNOWN), PROWLER SELECT PLUS ((B)(4)/LOT# UNKNOWN), CHIKAI/ASAHI INTECC, RADIFOCUS/TERUMO WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, GDC 10/BOSTON SCIENTIFIC (TOTAL 6). SOME OF THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS 1 OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00064, 1058196-2012-00065, 1058196-2012-00066, 1058196-2012-00067, 1058196-2012-00068, 1058196-2012-00069, 1058196-2012-00070, 1058196-2012-00071, 1058196-2012-00072, 1058196-2012-00073, 1058196-2012-00074, 1058196-2012-00075, 1058196-2012-00076, & 1058196-2012-00077.

    Description of Event or Problem · 1

    THE REPORT FROM THE CLINICAL STUDY (B)(4) FOR PATIENT WITH (B)(6) INDICATED THAT THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD ((B)(4)) AND MULTIPLE ORBIT COILS ((B)(4)) OF THE LEFT CAVERNOUS SINUS, AND THE DAY AFTER THE PROCEDURE, THE PATIENT DEVELOPED LEFT OCULOMOTOR PARALYSIS ASSOCIATED WITH ANEURYSM MASS EFFECT. BOTH MECOBALAMIN AND PREDNISOLONE WERE ADMINISTRATED FOR TREATMENT. THE EVENT OUT COME AS OF 7 MONTHS AFTER ONSET WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNRELATED. 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 13471449

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention