BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 3459578 · Received November 8, 2013

    Report

    Report Number
    1226348-2013-10084
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    April 20, 2012
    Report Date
    October 17, 2013
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS A MALE OF (B)(6) WITH MEDICAL HISTORIES OF HYPERTENSION, HYPERLIPEMIA AND CLIPPING OF INTERNAL CAROTID ARTERY. DOB AND WEIGHT UNKNOWN. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.5MM, AND THE NECK TO SAC RATIO WAS 4.5MM:9.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.0MM. MRS BEFORE THE PROCEDURE ON (B)(6) 2011 WAS 0, AFTER THE PROCEDURE ON (B)(6) 2011 21 WAS 0, ON (B)(6) 2011 WAS 0. THE ACT WAS 332 SECONDS POST ANTICOAGULATION BUT PRE ANTICOAGULATION WAS NOT MEASURED. NO INFORMATION REGARDING INR, PT AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE PROCEDURE. THE 1-YEAR FOLLOW-UP TOOK PLACE ON (B)(6) 201220, THE ANEURYSM NECK WAS 4.5MM, AND THE NECK TO SAC RATIO WAS 4.5MM:9.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.0MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%, MRS WAS 0. THE 2-YEAR FOLLOW-UP TOOK PLACE ON (B)(64 )2013 BUT THE ANGIOGRAPHY WAS NOT CONDUCTED. MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011 ~ (B)(6) 2010 AND (B)(6) 2012 ~ (B)(6) 2013, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011 ~ (B)(6) 2013, 50MG/DAY: (B)(6) 2013 ~ ONGOING, CILOSTAZOL 200MG/DAY: (B)(6) 2011 ~ (B)(6) 2013, 150MG/DAY: (B)(6) 2013 ~ ONGOING, HEPARIN 9000U: (B)(6) 2011, 6000U: (B)(6) 2011, 3000U: (B)(6) 2011, 12000U WAS ADMINISTRATED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, CELLO 8FR, 90CM/FUJI SYSTEMS, PROWLER SELECT PLUS ((B)(6)), RADIFOCUS GT 180CM 0.016INCH (TYPE 90 DEGREES)/TERUMO WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10 (TYPE J, TYPE 45 DEGREES AND TYPE STR/STRYKER(TOTAL 3), ECHELON 10 (TYPE STR)/COVIDIEN (B)(4), RADIFOCUS GT 180CM 0.012INCH (TYPE 90 DEGREES)/TERUMO, SILVERSPEED 200CM 0.016INCH/COVIDIEN (B)(4), ORBIT GALAXY ((B)(4)), ED COIL EXTRASOFT (2MM X 3CM TOTAL2, 2MM X 2CM TOTAL2)/KANEKA. DURING THE PROCEDURE, TRANS-CELL TECHNIQUE WAS UTILIZED. HOWEVER, REGARDING THE ADDITIONAL COIL EMBOLISATION, THERE IS NO INFORMATION ABOUT BOTH THE UTILIZED DEVICES AND THE IMPLANTED COILS. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: CELLO 8FR (DETAILS UNKNOWN); 90CM/FUJI SYSTEMS (DETAILS UNKNOWN); PROWLER SELECT PLUS ((B)(4); RADIFOCUS GT 180CM 0.016INCH (TYPE 90 DEGREES)/TERUMO (DETAILS UNKNOWN;) EXCELSIOR SL10 (TYPE J, TYPE 45 DEGREES AND TYPE STR/STRYKER(TOTAL 3) (DETAILS UNKNOWN); ECHELON 10 (TYPE STR)/COVIDIEN (B)(4) (DETAILS UNKNOWN); RADIFOCUS GT 180CM 0.012INCH (TYPE 90 DEGREES)/TERUMO (DETAILS UNKNOWN); SILVERSPEED 200CM 0.016INCH/COVIDIEN (B)(4) (DETAILS UNKNOWN); ORBIT GALAXY((B)(4); ED COIL EXTRASOFT (2MM X 3CM TOTAL2, 2MM X 2CM TOTAL2)/KANEKA (DETAILS UNKNOWN). THIS IS 1 OF 3 REPORTS ASSOCIATED WITH (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) PMS ENTERPRISE STUDY ANEURYSM GROWTH ONE YEAR FOLLOW-UP POST ENTERPRISE VRD ASSISTED COILING OF A RIGHT INTERNAL CAROTID ARTERY (RICA) DORSAL WALL ANEURYSM USING FOUR CODMAN ORBIT GALAXY COILS ((640CX0304/13500200 TOTAL2, 640CX2535/13500209, 640CX2525/13500182) AND FOUR NON-CODMAN COILS (ED COIL/KANEKA EXTRASOFT 2MM X 3CM TOTAL2, 2MM X 2CM TOTAL2). FIVE MONTHS LATER AN ADDITIONAL COIL EMBOLIZATION WAS PERFORMED WITH SATISFACTORY ANGIOGRAPHIC APPEARANCES WITH NO ISSUES NOTED. THE EVENT WAS INDICATED AS RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED. THE (B)(6) YEAR OLD MALE PATIENT HAD A MEDICAL HISTORY OF HYPERTENSION, HYPERLIPIDEMIA AND CLIPPING OF INTERNAL CAROTID ARTERY. AT INDEX PROCEDURE THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.5MM, AND THE NECK TO SAC RATIO WAS 4.5MM:9.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.0MM. THE MODIFIED RANKIN SCALE (MRS) SCORE PRE-PROCEDURE, IMMEDIATELY POST PROCEDURE AND TWO MONTHS POST PROCEDURE WAS 0. INTRAPROCEDURAL HEPARIN WAS ADMINISTERED WITH ACT OF 332 SECONDS POST ANTICOAGULATION BUT PRE ANTICOAGULATION WAS NOT MEASURED. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE INDEX PROCEDURE. AT YEAR FOLLOW-UP THE ANEURYSM NECK WAS 4.5MM, AND THE NECK TO SAC RATIO WAS 4.5MM:9.0MM WITHOUT CHANGE IN THE PARENT VESSEL DIAMETER. THERE IS NO INFORMATION REGARDING THE ADDITIONAL COIL EMBOLIZATION. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 3.0MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%, MRS WAS 0. THE 2-YEAR FOLLOW-UP TOOK PLACE BUT ANGIOGRAPHY WAS NOT CONDUCTED; THE MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY FROM 3 DAYS PRE-INDEX UNTIL 2 MONTHS POST INDEX AND STARTING ONE WEEK POST FOLLOW-UP COILING FOR 4.5 MONTHS. CLOPIDOGREL SULFATE 75MG/DAY AND CILOSTAZOL 200MG/DAY WAS ONGOING FOR APPROXIMATELY 15 MONTHS BEGINNING 3 DAYS PRE-INDEX PROCEDURE FOLLOWED BY ONGOING CLOPIDOGREL 50MG/DAY. THE COILS REMAIN IMPLANTED. REVIEW OF DEVICE HISTORY RECORDS FOR THE LOTS OF CODMAN COILS IMPLANTED REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. THE IFU PRECAUTIONS THAT MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME VESSELS OR ANEURYSMS. CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT WITH NO INDICATION OF ANY RELATED MANUFACTURING OR DEVICE PERFORMANCE ISSUES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    ((B)(4)). ANEURYSM GROWTH. THIS COMPLAINT IS FROM A CLINICAL STUDY ¿JAPAN PMS ENTERPRISE¿ #220-04. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2011. THE PROCEDURE WAS COIL EMBOLISATION ASSISTED WITH VRD ((B)(4)) FOR DORSAL WALL OF RIGHT INTERNAL CAROTID ARTERY. AT THE ONE YEAR FOLLOW-UP ON (B)(6) 201220, THE ANGIOGRAM REVEALED AN ANEURYSM GROWTH OF THE TREATED ANEURYSM NECK. ON (B)(6) 2012, AN ADDITIONAL COIL EMBOLISATION WAS PERFORMED. AFTER THE PROCEDURE, THE ANGIOGRAPHIC APPEARANCES WERE SATISFACTORY AND THERE WAS NO ISSUES NOTED. THE EVENT OUTCOME AS OF (B)(6) 2012 WAS INDICATED AS ¿RESOLVED WITHOUT SEQUELAE.¿ 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
    577767 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 13500200

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR