BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2452652 · Received February 10, 2012

    Report

    Report Number
    2954740-2012-00012
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    July 11, 2012
    Report Date
    January 12, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE EVENT IS FROM A CLINICAL STUDY PERFORMED IN (B)(6). THE EVENT IS BEING SUBMITTED AS A PRELIMINARY REPORT. AT THIS POINT, WE HAVE NOT BEEN ABLE TO CONFIRM IF MICRUS COILS WERE INVOLVED IN THE INITIAL COIL EMBOLIZATION THAT LED TO "COIL COMPACTION." AS MORE INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH VRD OF RIGHT CAVERNOUS SINUS. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2011. DURING THE 1 YEAR F/U VISIT ON (B)(6) 2011, IT WAS FOUND THAT THE PT DEVELOPED COIL COMPACTION AT THE ANEURYSM NECK. ACTION TAKEN WAS A REPEAT COIL EMBOLIZATION AND ADD'L VRD (DETAILS UNK). THE EVENT OUTCOME AS OF (B)(6) 2011 WAS "RECOVERED WITHOUT SEQUEL." ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT AND VRD TO THE INDEX PROCEDURE WAS UNRELATED. NO PRODUCT MALFUNCTIONS WERE NOTED. THE PT WAS A FEMALE OF (B)(6) WITH A HISTORY OF DYSLIPIDEMIA. ANTIPLATELET THERAPY INCLUDED ASPIRIN 300 MG/DAY: (B)(6) 2010, 100 MG/DAY: (B)(6) 2010 APPROX, CLOPIDOGREL SULFATE 300 MG/DAY: (B)(6) 2010, 75 MG/DAY: (B)(6) 2010 APPROX. HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE ACT WAS 151 SECONDS PRE ANTICOAGULATION AND 255 SECONDS POST ANTICOAGULATION. NO INFO REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 96% AFTER THE PROCEDURE ON (B)(6) 2010. MRS ON (B)(6) 2010 WAS 0, ON (B)(6) 2010 WAS 0, AND ON (B)(6) 2010 WAS 0. AT THE TIME IF THE 1-YEAR F/U (ON (B)(6) 2011), THE ANEURYSM NECK WAS 5.9MM, AND THE NECK TO SAC RATIO WAS 5.9MM, 10.6MM. MRS WAS 0 WITH OCCLUSION RATE OF 80%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F55046

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention