BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 1944267 · Received December 20, 2010

    Report

    Report Number
    2954740-2010-00024
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 24, 2009
    Report Date
    July 5, 2010
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. W/O THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THIS LOT.

    Description of Event or Problem · 1

    NOTE: THE (B)(4) ADJUDICATED THE INCIDENT TO BE DEVICE RELATED ON (B)(4) 2010. SUBJECT WAS ENROLLED IN (B)(4) STUDY. PER REC'D REPORT: THE SUBJECT WAS ENROLLED (B)(4) 2009. ON (B)(6) 2009, A DIAGNOSIS OF AN UNRUPTURED ANEURYSM WAS MADE: MRA SHOWED A PARTIALLY THROMBOSED ANEURYSM OF THE RIGHT CAROTID SIPHON RESPONSIBLE FOR BRAIN STEM MASS EFFECT. THE SUBJECT'S MRS SCORE WAS 3. THE SUBJECT WAS TREATED ON (B)(6) 2009. THE LARGE, IRREGULARLY SHAPED ANEURYSM OF THE RIGHT PCOM WAS 15X8X7MM. EIGHT COILS WERE PLACED AND A STENT WAS DEPLOYED AFTER COILING. RESIDUAL FILLING OF THE ANEURYSM NECK AND DOME WAS NOTED AT THE END OF THE PROCEDURE. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009, WITH MRS 3 AND REMAINED AT 3 AT ONE MONTH F/U ON (B)(6) 2009. PT WAS RE-HOSPITALIZED ON (B)(6), 2009. ANGIOGRAPHIC AND MRA IMAGING SHOWED SEVERE PERIANEURYSMAL REACTION WHICH WAS DETERMINED TO BE RESPONSIBLE FOR THE INCREASED MASS EFFECT AND EDEMA. FACIAL PALSY AND LEFT HEMIPARESIS THAT HAD STARTED 10 DAYS PRIOR TO THE EXAM WAS PROGRESSING. THE SYMPTOMS WERE RESOLVED AFTER CORTICOID THERAPY (PREDNIZONE 240MG FOR 7 DAYS AND THEN 120MG P), QD FROM (B)(6) 2009 UNTIL (B)(6) 2009. PT RETURNED ON (B)(6) 2010, AND MRS REMAINED AT 3. MRI SHOWED SEVERE MASS EFFECT WITH REAPPEARANCE OF THE LEFT HEMIPARESIS. ANGIOGRAM ON (B)(6) 2010 SHOWED PERSISTENT FILLING OF THE NECK AND DOME, THE RECURRENCE WAS TREATED WITH PVO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR