BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2418572 · Received January 17, 2012

    Report

    Report Number
    1058196-2012-00024
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    May 10, 2011
    Report Date
    January 13, 2012
    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

    CORRECTED DATA: THE INITIAL SUBMISSION OF THIS REPORT INDICATED THE INVOLVED DEVICE WAS THE ENTERPRISE VRD; HOWEVER, AS REPORTED IN THE INITIAL REPORT (1058196-2011-00544), THE INVOLVED DEVICES ARE THE IMPLANTED COILS. AS SUCH THIS IS BEING CORRECTED TO REFLECT THE INVOLVED DEVICES IN SECTION D OF THESE MFG REPORTS: 1058196-2012-00020, 1058196-2012-00021, 1058196-2012-00022, 1058196-2012-00023, AND 1058196-2012-00025. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.9MM, AND THE NECK TO SAC RATIO WAS 7.9:19.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.8MM AND DISTALLY WAS 4.2MM. MRS ON (B)(6) 201 WAS 0, ON (B)(6) 2010 WAS 0, AND ON (B)(6) 2010 WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: START DATE UNK ~ONGOING, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2010 ~ (B)(6) 2011, 50MG/DAY: (B)(6) 2011 ~ 2011, 25MG/DAY: (B)(6) 2011 ~ 2011, 150MG/DAY: (B)(6) 2011, 75MG/DAY: (B)(6) 2011 ~ 2011, 50MG/DAY: (B)(6) 2011, ARGATROBAN HYDRATE 60MG/DAY: (B)(6) 2010 ~ (B)(6) 2010, 60MG/DAY: (B)(6) 2011 ~ (B)(6) 2011. HEPARIN 6000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE ACT WAS 131 SEC PRE ANTICOAGULATION AND 262 SEC POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, A BRITE TIP GUIDE CATHETER, PROWLER SELECT PLUS (MC) MICROCATHETER (606-S255X/LOT UNK), AND A CHIKAI GUIDEWIRE (ASAHI) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE AN EXCELSIOR 1018 MC, GDC COILS X16 (BS), ORBIT COIL X5 (637CS183/LOT UNK), ORBIT COILS X7 (637CF0824/LOT UNK), ORBIT COILS X3 (637CS1430/LOT UNK), ORBIT COILS (637CS1030/LOT UNK), MICROSPHERE COIL (MICRUS), ORBIT COILS X3 (637CF0515/LOT UNK), ORBIT COILS (637MF0306/LOT UNK), AND HELIPAQ COILS X10 (MICRUS). NEITHER FURTHER INFORMATION NOR PROCEDURAL IMAGES WERE AVAILABLE. THE LOT NUMBERS OF THE DEVICES ARE NOT KNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEWS CANNOT BE COMPLETED. ANEURYSM RECANALIZATION 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 NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. PROCEDURAL FACTORS AND VESSEL/ANEURYSM CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED ANEURYSM RE-CANALIZATION. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS THREE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00020, 1058196-2012-00021, 1058196-2012-00022, 1058196-2012-00023, AND 1058196-2012-00025.

    Description of Event or Problem · 1

    THE REPORT FORM CLINICAL STUDY (B)(6) PMS ENTERPRISE FOR PATIENT WITH (B)(6) INDICATED THAT THE SEVEN MONTH AFTER THE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812/01422404) OF BA-TRUNK, FOLLOW-UP ANGIOGRAPHIC SHOWED THAT THE PATIENT DEVELOPED COIL COMPACTION AT THE ANEURYSM NECK. ACTION TAKEN WAS A REPEAT COIL EMBOLIZATION AND PLACEMENT OF ANOTHER ENTERPRISE VRD (CATALOG/LOT UNKNOWN) THREE MONTHS AFTER CONDUCTING THE ANGIOGRAPHY. ADDITIONALLY, DURING THE INDEX PROCEDURE, THE COIL IMPLANTED IN THE ANEURYSMS CONSISTED OF GDC COILS X16 (BS), ORBIT COIL X5 (637CS1830/LOT UNK), ORBIT COILS X7 (637CF0824/LOT UNK), ORBIT COILS X3 (637CS1430/LOT UNK), ORBIT COIL X1(637CS1030/LOT UNK), MICROSPHERE COIL (MICRUS), ORBIT COILS X3 (637CF0515/LOT UNK), ORBIT COIL X1(637MF0306/LOT UNK), AND HELIPAQ COILS X10 (MICRUS). THE EVENT OUTCOME FOUR MONTHS AFTER ANGIOGRAPHY WAS RECOVERED WITHOUT SEQUEL. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE ENTERPRISE VRD WAS ALSO UNRELATED. NO PRODUCT MALFUNCTIONS WERE NOTED. NO COIL OR COILS PROTRUDED THROUGH THE VRD DURING THE SECOND PROCEDURE, AND THERE WAS NO DIFFICULT CROSSING THE VRD WITH THE MICROCATHETER DURING THE SECOND PROCEDURE.

    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 65 YR Required Intervention