BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2261455 · Received September 21, 2011

    Report

    Report Number
    2954740-2011-00056
    Event Type
    Other
    Date Received
    September 21, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BELOW ARE LIST OF DEVICES USED IN THE PROCEDURE. NO LOT NUMBER WAS PROVIDED. DELTAPLUSH 10 (B)(4), CASHMERE 14 (B)(4), DELTAPLUSH 10 (B)(4), DELTAPLUSH 10 (B)(4) .

    Description of Event or Problem · 1

    NOTE: EVENT WAS FROM A PACKING DENSITY IN (B)(4) STUDY. SUBJECT IS A (B)(6) MALE, NON-SMOKER, HISTORY OF HYPERTENSION AND DIABETES MELLITUS, BUT NON-COMPLIANT FOR MEDICATION. SUBARACHNOID HEMORRHAGE WITH RUPTURE OF ACOM ANEURYSM LIKELY (B)(6) 2011, WITH SUBSEQUENT RE-RUPTURE (B)(6) 2011. UNDERWENT ANGIOGRAM WITH COILING OF RUPTURED ACOM ANEURYSM (4.1 MM HEIGHT, 4.6 MM WIDTH, 3.9 MM DEPTH, 2 MM NECK), FIRST COIL PLACED RESULTED IN INTRAPROCEDURAL PERFORATION. UPON PLACEMENT OF THE FIRST COIL INTO THE RUPTURED ACOM ANEURYSM, THERE WAS A SMALL HERNIATION OF A LOOP LATERALLY WHICH WAS FELT TO BE POSSIBLY EXTRINSIC. ANGIOGRAM CONFIRMED EXTRAVASATION. THE REMAINING 5 COILS WERE RAPIDLY PLACED OVER 4 MINUTES. FOLLOW-UP ANGIOGRAM REVEALED COMPLETE THROMBOSIS OF THE ANEURYSM AND NO RESIDUAL EXTRAVASATION. SITE INDICATED THE EVENT WAS PROCEDURAL RELATED AND POSSIBLY RELATED TO THE MICRUS COIL AND/OR PROCEDURE. MONITOR INDICATES EVENT IS PROCEDURAL RELATED AND POSSIBLY RELATED TO THE DEVICE. NO PARENCHYMAL HEMORRHAGE OR MIDLINE SHIFT. SUBJECT DISCHARGED ON (B)(6) 2011, WITH MODIFIED RANKIN SCORE OF 0: NO SYMPTOMS AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1