BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2840711 · Received November 20, 2012

    Report

    Report Number
    2954740-2012-00790
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    April 5, 2011
    Report Date
    September 11, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Removal / Correction Number
    2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00789 AND 2954740-2012-00790. THE REPORT FROM THE (B)(4) PMS ENTERPRISE CLINICAL STUDY INDICATED THAT THERE WAS RECANALIZATION OF THE TREATED RIGHT INTRACRANIAL VERTEBRAL ARTERY ANEURYSM MONTHS AFTER THE ENTERPRISE VRD ASSISTED COILING WITH FOUR CODMAN COILS (CRC140408-30/LOT UNKNOWN AND CDF100410-30/LOT UNKNOWN, TOTAL 3), AND 27 NONCODMAN COILS (ED 14 COILS/KANEKA, TOTAL 24 AND V-TRACK HYDROCOIL 10/TERUMO, TOTAL 3). POST INDEX PROCEDURE THE ANEURYSM OCCLUSION RATE WAS 95%. AT THE TIME OF 3 MONTH FOLLOW-UP THE DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED COIL COMPACTION. ACTION TAKEN WAS ADDITIONAL COIL EMBOLIZATION THAT TOOK PLACE TWO DAYS LATER. THE EVENT OUTCOME WAS INDICATED AS "RESOLVED WITHOUT SEQUELAE" ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNRELATED. AT BASELINE THE (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF BRONCHIAL ASTHMA WAS TREATED FOR A DISSECTING UNRUPTURED FUSIFORM RIGHT VERTEBRAL ARTERY (VA) ANEURYSM. THE NECK WAS 15.5MM, AND THE NECK TO SAC RATIO WAS 15.5MM: 12.4MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.5MM AND DISTALLY WAS 2.9MM. THE MODIFIED RANKIN SCALE (MRS) SCORE PRE-PROCEDURE, TWO DAYS POST PROCEDURE, AND ONE MONTH POST PROCEDURE WAS 0. AN UNKNOWN DOSE OF HEPARIN WAS ADMINISTERED INTRAPROCEDURALLY. DURING THE INDEX PROCEDURE, ONE OF THE ED COILS/KANEKA UNRAVELED FOR UNKNOWN REASONS. AN ADDITIONAL VRD (ENC453712/01425067) WAS PLACED IN RIGHT VERTEBRAL ARTERY. IT IS UNKNOWN IF THE 2ND VRD WAS IMPLANTED PROXIMAL OR DISTAL TO, OR OVERLAPPING WITH THE 1ST VRD. THE EVENT OUTCOME TWO DAYS LATER WAS INDICATED AS "RESOLVED WITHOUT SEQUELAE." ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED. ANTIPLATELET THERAPY INCLUDED ONGOING ASPIRIN 100MG/DAY THE BEGINNING THE DAY OF THE PROCEDURE AND ONGOING CLOPIDOGREL 75MG/DAY BEGINNING ONE MONTH PRIOR TO THE PROCEDURE WITH 300MG/DAY FOR ONE DAY AT INDEX PROCEDURE DAY. DURING THE 3 MONTHS FOLLOW-UP, THE DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED COIL COMPACTION. STAGED COIL EMBOLIZATION WAS PERFORMED TWO DAYS LATER. THE PREVIOUSLY-TREATED UNRUPTURED FUSIFORM ANEURYSM NECK WAS 11.0MM, AND THE NECK TO SAC RATIO WAS 11.0MM:11.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL AND DISTALLY WAS NOT MEASURED. THE MRS SCORE BEFORE THE STAGED PROCEDURE AND POST PROCEDURE WAS 0. HEPARIN 6,000U WAS ADMINISTRATED INTRA-PROCEDURALLY. THE ACT PRE ANTICOAGULATION WAS NOT MEASURED BUT WAS 265 SECONDS POST ANTICOAGULATION. DURING THE STAGED PROCEDURE, AFTER PLACING THE MICROPLEX COMPASS/TERUMO IN THE TARGET ANEURYSM WHEN PULLING THE EXCELSIOR SL10 OUT FROM THE ANEURYSM, IT WAS REALIZED THAT THE PROXIMAL SECTION OF THE MICRO PLEX FOLLOWED TO THE MICROCATHETER(EXCELSIOR SL10) AND PROTRUDED INTO THE VRD LUMEN. THEREFORE, THE DECISION WAS MADE TO PLACE TWO VRDS (BOTH ENC452812/ 01424296) SO AS TO COVER THE UNRAVELED SECTION OF THE COIL WITH THE VRD, AS WELL AS TO DIVERT BLOOD FLOW AWAY FROM THE ANEURYSM AND DECREASE FLOW VELOCITY IN THE ANEURYSM BY PLACING TWO VRDS. THE ENTERPRISE VRD INSTRUCTIONS FOR USE PRECAUTIONS THAT THE ENTERPRISE VRD IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE PROCEDURE. THE EVENT OUTCOME AS OF FIVE DAYS POST PROCEDURE WAS INDICATED AS "RESOLVED WITHOUT SEQUELAE" ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNRELATED. THE OCCLUSION RATE AT ONE YEAR FOLLOW-UP WAS 90%. THE LOT NUMBERS OF THE IMPLANTED COILS ARE NOT AVAILABLE; THEREFORE, THE DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. THE EMBOLIC COILS REMAIN IMPLANTED AND INDEX AND FOLLOW-UP PROCEDURAL IMAGES ARE NOT AVAILABLE. 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. ADDITIONALLY IT PRECAUTIONS THAT THE ENTERPRISE VRD IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E. WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NOTE: A CORRECTION IS BEING SUBMITTED TO INFORM YOU THAT THE WRONG DEVICE TYPE WAS CAPTURED AND REPORTED UNDER MEDWATCH REPORT NUMBERS (B)(4). IN REFERENCE TO THE DEVICE(S) REPORTED ON THE ABOVE MDR NUMBERS INDICATED, THE CORRECT DEVICE IS NOW BEING CAPTURED. EVENT DESCRIPTION: DURING THE 3 MONTHS FOLLOW-UP THAT TOOK PLACE, THE DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED COIL COMPACTION. ACTION TAKEN WAS ADDITIONAL COIL EMBOLISATION. DURING THE STAGED PROCEDURE, AFTER PLACING THE MICROPLEX COMPASS/TERUMO IN THE TARGET ANEURYSM AND THEN WHEN THE PHYSICIAN PULLED OUT EXCELSIOR SL10 OUT FROM THE ANEURYSM, HE REALISED THAT THE PROXIMAL SECTION OF THE MICRO PLEX FOLLOWED TO THE MICROCATHETER (EXCELSIOR SL10) AND PROTRUDED INTO THE VRD LUMEN. THEREFORE, THE DECISION WAS MADE TO PLACE TWO VRDS (BOTH (B)(4)) SO AS TO COVER THE UNRAVELED SECTION OF THE COIL WITH THE VRD, AS WELL AS TO DIVERT BLOOD FLOW AWAY FROM THE ANEURYSM AND DECREASE FLOW VELOCITY IN THE ANEURYSM BY PLACING TWO VRDS. THE EVENT OUTCOME WAS INDICATED AS "RESOLVED WITHOUT SEQUELAE" ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNRELATED. THE PREVIOUSLY-TREATED UNRUPTURED FUSIFORM ANEURYSM NECK WAS 11.0 MM, AND THE NECK TO SAC RATIO WAS 11.0 MM:11.0 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL AND DISTALLY WAS NOT MEASURED. MRS BEFORE THE STAGED PROCEDURE 0, AND AFTER THE PROCEDURE WAS 0. THE ACT PRE ANTICOAGULATION WAS NOT MEASURED, BUT 265 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE PROCEDURE. IT IS UNKNOWN WHY IT WAS NOT PACKED FURTHER. PRIOR TO IMPLANTING THE VRD, CELLO/FUJI SYSTEMS CO: (B)(4) (LOT#UNKNOWN); X-PEDION/COVIDIEN (B)(4) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE: EXCELSIOR SL10, X-CELERATOR/COVIDIEN (B)(4), MICROPLEX COMPASS/ TERUMO (TOTAL 2). NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS PROCEDURE AND THE PROCEDURAL IMAGES ARE NOT AVAILABLE. ON ONE-YEAR FOLLOW UP THAT WAS CONDUCTED, THE OCCLUSION RATE OF THE ANEURYSM WAS 90%, AND THE ANEURYSM NECK TO SAC RATIO WAS 11.0 MM: 11.9 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.9 MM AND DISTALLY WAS 2.5 MM, AND MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100 MG/DAY: ONGOING, CLOPIDOGREL SULFATE 300 MG/DAY: 75 MG/DAY; UNKNOWN DOSAGE OF HEPARIN WAS ADMINISTERED INTRA-PROCEDURALLY. HEPARIN 6,000U WAS ADMINISTRATED INTRA-PROCEDURALLY. CONCOMITANT DEVICES USED: PRIOR TO IMPLANTING THE VRD, CELLO/FUJI SYSTEMS CO: (B)(4) (LOT# UNKNOWN), X-PEDION/COVIDIEN (B)(4) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, X-CELERATOR/COVIDIEN (B)(4), MICROPLEX COMPASS/ TERUMO (TOTAL 2).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A CLINICAL STUDY. AS INDEX PROCEDURE TOOK PLACE, THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH VRD ((B)(4)) OF RIGHT INTRACRANIAL VERTEBRAL ARTERY. DURING THE INDEX PROCEDURE, ONE OF THE ED COILS/KANEKA UNRAVELED FOR UNKNOWN REASONS. ADDITIONAL VRD ((B)(4)) WAS PLACED IN RIGHT VERTEBRAL ARTERY. IT IS UNKNOWN IF THE 2ND VRD IMPLANTED PROXIMAL OR DISTAL TO, OR OVERLAP WITH THE 1ST VRD. THE EVENT OUTCOME AS OF WAS INDICATED AS "RESOLVED WITHOUT SEQUELAE". ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED. THE PATIENT HAD MEDICAL HISTORY OF BRONCHIAL ASTHMA. THE DISSECTING UNRUPTURED FUSIFORM ANEURYSM NECK WAS 15.5 MM, AND THE NECK TO SAC RATIO WAS 15.5 MM: 12.4 MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.5 MM AND DISTALLY WAS 2.9 MM. MRS WAS 0, TWO DAYS AFTER, IT REMAINED 0. NO INFORMATION REGARDING ACT, INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, (B)(4), TWO (B)(4) (LOT NUMBER UNKNOWN), TRAXCESS 14/TERUMO WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE: EXCELSIOR SL10, ED 14 COILS/KANEKA (TOTAL 24),(B)(4) (LOT UNKNOWN), (B)(4) (LOT UNKNOWN, TOTAL 3), V-TRACK HYDROCOIL 10/TERUMO (TOTAL 3) . PROCEDURAL IMAGES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention