BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2921652 · Received January 18, 2013

    Report

    Report Number
    1058196-2013-00021
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2011
    Report Date
    December 26, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY 17 MONTHS AFTER THE INDEX PROCEDURE. THE CAUSE OF THE DEATH WAS UNKNOWN. ACCORDING TO THE PATIENT¿S FAMILY, WHO MADE THE REPORT, THE PATIENT WAS FOUND DEAD WHILE SHE WAS WATCHING TV. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT FOR NOW. THE DEVICES REMAIN IMPLANTED AND ARE NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01423723. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DHR REVIEW FOR THE COIL COULD NOT BE PERFORMED DUE TO THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT¿S PAST MEDICAL HISTORY OF HYPERLIPEMIA AND ANEURYSM ARE FACTORS THAT POSSIBLY IMPACTED THE REPORTED OUTCOME. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE PATIENT SUBSEQUENT DEATH. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS FOR COMPLAINT (B)(4) AND IS ASSOCIATED WITH TWO DIFFERENT MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS A MEDICAL HISTORY OF HYPERLIPEMIA AND PREVIOUS COIL EMBOLIZATION FOR LEFT CEREBRAL ARTERY ANEURYSM. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 12.0MM, AND THE NECK TO SAC RATIO WAS 12.0MM:30.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.4MM AND DISTALLY WAS 3.0MM. MRS BEFORE THE INDEX PROCEDURE ON (B)(6) 2011 WAS 0, ON (B)(6) 2011 WAS 0, ON (B)(6) 2011 WAS 0. THE ACT WAS 380 SECONDS POST ANTICOAGULATION. THE ACT WAS NOT PERFORMED PRE ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE INDEX PROCEDURE. AT THE TIME OF FOLLOW-UP (ON (B)(6) 2011), THE ANEURYSM NECK WAS 12.0MM, AND THE NECK TO SAC RATIO WAS 12.0MM:30.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.4MM AND DISTALLY WAS 3.0MM. THE OCCLUSION RATE OF ANEURYSM WAS 70%. MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2010 ~ (B)(6) 2012, ASPIRIN 200MG/DAY: (B)(6) 2012, CLOPIDOGREL SULFATE 50MG/DAY: (B)(6) 2011 ~ (B)(6) 2012, CILOSTAZOL 200MG/DAY: (B)(6) 2011, HEPARIN 10,000U: (B)(6) 2011 ~ (B)(6) 2012, ARGATROBAN HYDRATE 40MMG/DAY: (B)(6) 2011, 30MG: (B)(6) 2012. PRIOR TO IMPLANTING THE VRD AT THE TIME OF INDEX PROCEDURE, SHUTTLE/COOK INC, 606-S255X(CAT/LOT UNKNOWN). OTHER DEVICES UTILIZED DURING THE INDEX PROCEDURE WERE, EXCELSIOR SL-10/STRYKER, RADIFOCUS GT GW/TERUMO, ORBIT COILS (CAT/LOT UNKNOWN, TOTAL 28). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE LOT NUMBERS OF THE IMPLANTED CODMAN COILS ARE NOT AVAILABLE; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. ANEURYSM GROWTH 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 ANEURYSM AND NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. THE IFU PRECAUTIONS THAT MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME VESSELS OR ANEURYSMS. CLINICAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THE ACTUAL PRODUCT CATALOG AND LOT NUMBERS ARE UNKNOWN, THEREFORE, THE PRODUCT CAPTURED IN SECTION D 4 REPRESENTS UNKNOWN ORBIT COILS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY 17 MONTHS AFTER THE INDEX PROCEDURE. THE CAUSE OF THE DEATH WAS UNKNOWN. ACCORDING TO THE PATIENT¿S FAMILY, WHO MADE THE REPORT, THE PATIENT WAS FOUND DEAD WHILE SHE WAS WATCHING TV. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT FOR NOW. THIS IS ONE OF 28 PRODUCTS THAT WERE IMPLANTED AND IT IS UNKNOWN WHICH ONE IF ANY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(6) REPORTED THAT ELEVEN MONTHS AFTER THE INDEX PROCEDURE OF THE LEFT PARASELLAR WITH AN ENTERPRISE VRD (ENC453712/01423723) AND 28 ORBIT COILS (CATALOG AND LOT NUMBER UNKNOWN), AND ANGIOGRAM REVEALED A RECANALIZATION OF THE TREATED ANEURYSM DUE TO COIL COMPACTION. ACTION TAKEN WAS AN ADDITIONAL COIL EMBOLIZATION AND MEDICATION. AFTER THE PROCEDURE, THE ANGIOGRAPHIC APPEARANCES WERE SATISFACTORY AND THERE WAS NO ISSUES NOTED. THE EVENT OUTCOME AS OF A MONTH AFTER THE EVENT WAS RESOLVED WITHOUT SQUEALED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27955 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention