BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2473771 · Received February 28, 2012

    Report

    Report Number
    2954740-2012-00024
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    December 9, 2010
    Report Date
    January 30, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE CATALOG AND LOT NUMBERS, INCLUDING THEIR RESPECTIVE MFG AND EXPIRATION DATES ARE UNK. THE PRODUCT(S) WERE IMPLANTED DURING THE CLINICAL STUDY AND WERE NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE(S), THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED IF ANY, COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    NOTE: THE EVENT WAS FROM AN (B)(6) CLINICAL STUDY PERFORMED IN (B)(6). ON (B)(6) 2010 THE PT UNDERWENT ENTERPRISE STENT ASSISTED COILING OF AN INTERNAL CAROTID (IC) ARTERY ANEURYSM. THE COILS PLACED IN THE ANEURYSM INCLUDED V-TRACK (TOTAL 4), MICRUS DELTAPLUSH 10 (TOTAL 14), MICRUS DELTAPAQ 10 (TOTAL 3), MICRUS CASHMERE 14 (TOTAL 4). THE ANEURYSM OCCLUSION RATE WAS 95% WITH NO PROCEDURAL COMPLICATIONS. THE ONE YEAR FOLLOW-UP ANGIOGRAPHY REVEALED ANEURYSM RE-GROWTH OF THE LEFT PARACELLAR IC ANEURYSM; THE OCCLUSION RATE WAS 50%. THE ANEURYSM NECK TO SAC RATIO WAS 9.0MM:9.0MM. THE PHYSICIAN CONSIDERED THAT IT WAS NATURAL COURSE OF THE SYMPTOM AND NO ACTION WAS TAKEN. THE EVENT OUTCOME ONE MONTH POST ONE-YEAR FOLLOW-UP WAS INDICATED AS "ONGOING, UNCHANGED". ANTIPLATELET THERAPY INCLUDED ASPIRIN 100 MG/DAY: 2010 (B)(6) AND ONGOING. CLOPIDOGREL SULFATE 75 MG/DAY: 2010 - (B)(6) 2011 AND ONGOING. CILOSTAZOL 200 MG/DAY: (B)(6) 2011. ARGATROBAN HYDRATE 60 MG/DAY: (B)(6) 2010, 40 MG/DAY, (B)(6) 2010 TO (B)(6), 20 MG/DAY: (B)(6) 2010 TO (B)(6) 2011. HEPARIN 7000U WAS ADMINISTERED INTRA-PROCEDURALLY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening