BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 1980376 · Received February 3, 2011

    Report

    Report Number
    2954740-2011-00007
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 7, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORP
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL DEVICES USED IN THIS CASE WERE IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    NOTE: SUBJECT WAS ENROLLED IN (B)(4) STUDY. (B)(6) WAS ENROLLED ON (B)(6) 2010, WITH A DIAGNOSIS OF A LARGE, SYMPTOMATIC, UNRUPTURED ANEURYSM. THE MODIFIED RANKIN SCORE ON ADMISSION WAS 1. DIAGNOSTIC SCANS SHOWED THE FOLLOWING: MRI - VENTRICLES, SULCI, AND CISTERNS WERE MODERATELY PROMINENT. THERE WAS A MODERATE TO SEVERE BURDEN OF PATCHY AND CONFLUENT PERIVENTRICULAR AND HEMISPHERIC ABNORMAL WHITE MATTER HYPERINTERINTENSE ON FLAIR AND T2 IMAGES. IN ADDITION THERE WAS AN APPROX 1.5CM DIAMETER ARE OF ABNORMAL HYPERINTENSE SIGNAL ON FLAIR, T2 AND DIFFUSION IN THE LEFT PONS. THERE WAS ASSOCIATED DIMINISHED APPARENT DIFFUSION COEFFICIENT. THE MIDLINE STRUCTURES WERE NORMALLY LOCATED. THE ENHANCEMENT PATTERN WAS WITHIN NORMAL LIMITS. CT - SOFT TISSUE MASS AT THE LEFT ASPECT OF THE CAVERNOUS SINUS REPRESENTING ANEURYSM OR MENINGIOMA. MRA - THERE WAS A 9.5 MM DIAMETER LEFT POSTERIOR COMMUNICATING ARTERY AREA ANEURYSM ARISING FROM THE DISTAL LEFT INTERNAL CAROTID ARTERY. THERE WAS AN ADJACENT NON-DOMINANT LEFT POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM WAS TREATED ON (B)(6) 2010. THE PRE-OP ANGIOGRAM SHOWED A REGULAR SHAPED ANEURYSM LOCATED AT THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A 10 MM HEIGHT, 10 MM WIDTH AND A 6 MM NECK. THE OPERATIVE PROCEDURE WAS 3 HOURS 20 MINUTES. AFTER COILING WITH 17 CERECYTE COILS (PRESIDIO, DELTAPAQ AND DELTAPLUSH) FOR A TOTAL COIL LENGTH OF 215 MM, THE POST COILING ANGIOGRAPHIC GRADING SCALE WAS A 3 (RESIDUAL FILLING OF ANEURYSM NECK AND DOME). NO ADJUNCTIVE DEVICES WERE USED. AN MRA WAS PERFORMED ON (B)(6) 2010 WITH THE FOLLOWING RESULTS: STATUS POST LEFT P-COMM ANEURYSM COILING WITH PUNCTATE NECK FILLING AND PATENCY OF THE P-COMM ARISING FROM THE INFERIOR MEDIAL ASPECT OF THE COIL MASS. AN MRI WAS PERFORMED ON (B)(6) 2010 INTERVAL DEVELOPMENT OF DIFFUSE BUT SMALL AREAS OF EARLY SUBAC. THE PT WAS RE-ADMITTED FOR AN UNSCHEDULED VISIT ON (B)(6) 2010. PT PRESENTED WITH PROGRESSIVELY WORSENING LEFT EYE DROOP FOR APPROX 5 DAYS PRIOR TO ADMISSION ((B)(6) 2010). HER NEUROLOGIC SCAN WAS STABLE WITH LEFT-SIDED HEMIPARESIS. THE MRA REVEALED THE FOLLOWING: INTERVAL DEVELOPMENT OF A FEW SMALL FOCI OF DIFFUSION RESTRICTION WITHIN THE LEFT CEREBRAL HEMISPHERES LOCATED AT LEFT CAUDATE NUCLEUS HEAD, LEFT ASPECT OF THE CORPUS CALLOSUM GENU AND LEFT CENTRUM SEMIOVALE CONSISTENT WITH ACUTE ISCHEMIA. THESE ARE SUPERIMPOSED ON PREVIOUSLY VISUALIZED, CHRONIC, LATE AND EARLY SUBACUTE ISCHEMIC CHANGES WITHIN THE CEREBRAL HEMISPHERES BILATERALLY. INTERVAL INCREASED EDEMA IN THE LEFT ASPECT OF THE MIDBRAIN AND PONS TO LEFT OF THE MIDLINE AND MEDIAL LEFT TEMPORAL LOBE AROUND THE PT'S KNOWN ANEURYSM COIL MASS IN THE LEFT P-COMM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention| S