BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 2782163 · Received October 11, 2012

    Report

    Report Number
    2954740-2012-00742
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    December 8, 2011
    Report Date
    September 19, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K062036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION OF THE LEFT P-COM ASSISTED WITH AN ENTERPRISE (ENC452212) STENT AND COILS (PEDION-COVIDIEN, PC4181240-30/F58958), -TRACK/TERUMO (X9), ED-KANEKA (X2), AND CDF100410-30/G11849, INDICATED THAT 30 MINUTES AFTER THE PROCEDURE, THE PATIENT DEVELOPED INFARCTION AND HEMIPLEGIC IN LEFT BRAIN. INFUSION OF RADICUT AND REHABILITATION WERE PROVIDED, AND RECOVERY WAS CONFIRMED APPROXIMATELY TWO WEEKS AFTER ONSET, AND THE PATIENT WAS DISCHARGED. NO COIL WAS PROTRUDING INTO THE PARENT ARTERY, AND THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 0, AFTER AND WITHIN A WEEK WAS 1, AND AFTER 30 DAYS IT WAS 0 AND THE ACT PRE-PROCEDURE WAS NOT KNOWN, AND THE POST PROCEDURE WAS 264 SECONDS. PRODUCT UTILIZED CONSISTED OF PROWLER SELECT PLUS MICROCATHETER (MC), LAUNCHER GUIDING CATHETER, SL10 MC, ECHELON 10, TRAXESS GUIDEWIRE, SILVER SPEED GUIDEWIRE, DELTAPAQ (QTY 2), DELTA PLUSH (QTY 13), MICRO PLEX, AND HYDRO COIL. THE SPECIFICS ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY (DATE UNKNOWN), PLAVIX 75MG/DAY ((B)(6) 2010- (B)(6) 2011), AND PLAVIX 300MG/DAY ((B)(6) 2010). THE SACCULAR UNRUPTURED ANEURYSM MEASURED 6.3MM AT THE NECK AND THE NECK TO SAC RATION WAS 6.3MM/10.4MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO 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 LARGER ANEURYSM SIZE, NECK SIZE, PACKING DENSITY, AND INFLOW ANGLE. BASED ON THE AVAILABLE INFORMATION, ANEURYSM LOCATION AND CHARACTERISTICS/SIZE ARE POSSIBLE CONTRIBUTING FACTORS. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00298, 2954740-2012-00742 AND 2954740-2012-00743.

    Description of Event or Problem · 1

    THE REPORT FROM A CLINICAL STUDY (B)(6) FOR PATIENT WITH ID (B)(4) INDICATED THAT DURING THE ONE-YEAR FOLLOW UP, THE ANGIOGRAM REVEALED AN ANEURYSM GROWTH OF THE TARGET ANEURYSM (LEFT POSTERIOR COMMUNICATING ARTERY WHERE THE ENC 452212/13471974 DURING THE INDEX PROCEDURE. THE OCCLUSION RATE OF THE ANEURYSM AT THE TIME OF ONE YEAR FOLLOW UP WAS 80% (IT WAS 99% AFTER THE INDEX PROCEDURE), AND THE ANEURYSM NECK TO SAC RATIO WAS 6.3MM: 10.4MM. MRS WAS 0. THE PHYSICIAN CONSIDERED THAT IT WAS A NATURAL COURSE OF THE SYMPTOM AND NO ACTION WAS TAKEN. THE EVENT OUTCOME AS OF TWO MONTHS AFTER ONSET WAS ONGOING AND UNCHANGED. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 300MG: 75MG/DAY, AND HEPARIN 4000U INTRA-PROCEDURALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F58958

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention