BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUSPHERE 10 - CERECYTE MICROCOIL

    MDR report key: 2941464 · Received February 4, 2013

    Report

    Report Number
    1226348-2013-20001
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 31, 2011
    Report Date
    January 16, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K0022420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRAST CAT-SCAN (CCT) PERFORMED THE DAY AFTER THE INDEX PROCEDURE SHOWED NO BLEEDING, ALMOST ENTIRE RE-ABSORPTION OF CONTRAST MEDIUM EXTRAVASATIONS, AND NO LIQUOR CIRCULATION DISTURBANCE. CCT PERFORMED THREE DAYS AFTER THE PROCEDURE SHOWED THAT THE EXTERNAL VENTRICLE DRAINAGE WAS DISCONNECTED, NO LIQUOR CIRCULATION DISTURBANCE WAS NOTED, OR BLEEDING. CT PERFORMED SEVENTEEN DAYS AFTER THE INDEX PROCEDURE SHOWED NO BLEEDING, NO CIRCULATION DISTURBANCES, AND NO NEW ISCHEMIA SIGNS THE PATIENT WAS DISCHARGED TWENTY DAYS AFTER THE INDEX PROCEDURE WITH A WITH MRS OF 1. THE CONTROL ANGIOGRAPHIC PERFORMED SIX MONTHS AFTER THE INDEX PROCEDURE SHOWED A STABLE FULLY OCCLUDED ANEURYSM (RRGS 1), NO RE-BLEEDING, OR RECURRENCE. THE MRS WAS 0. IT WAS REPORTED THAT NINE DAYS PRIOR TO THE EVENT, THE PATIENT SUFFERED AN EXTREME HEADACHE AND WAS VOMITED ONCE. THE FAMILY DOCTOR PRESCRIBED PAIN MEDICATION AND ADVISED TO SEE AN ORTHOPEDIST. BECAUSE THE PAIN DID NOT DECREASED IN THE NEXT FEW DAYS AND THE SUBJECT COLLAPSED TWICE SHE WENT TO THE HOSPITAL. NO FINDING ON THE PERFORMED MRT OF THE CERVICAL-VERTEBRA AND SUBJECT WAS DISCHARGED TO HOME. PRIOR TO THE PROCEDURE, THE PATIENT CONSULTED THE ORTHOPEDIST AND WAS TRANSFERRED TO A NEUROLOGIST AFTER FINDINGS IN THE LUMBAR PUNCTURE (XANTHOCHROMIC LIQUOR) SHOWED ANEURYSM AT THE BASILAR TIP. THE PATIENT WAS THEN TRANSFERRED TO THE HOSPITAL THE DAY OF THE PROCEDURE, AND THE DSA PERFORMED SHOWED A RUPTURED REGULAR ANEURYSM AT THE BASILAR TIP (RIGHT P1 SEGMENT), AND THE CT SHOWED NO ACUTE BLEEDING. THE MEASURED DIMENSION WERE 6.8 MM DOME HIGHT, 4.6 MM DOME WIDTH, 6.0 MM DOME DEPTH AND THE NECK 4.6 MM. AT THE DOME A SMALL "DAUGHTER-ANEURYSM" WAS SEEN. AS WELL "NARROWNESS" (VERY LIKELY DUE TO SPASMS) AT THE PROXIMAL LEFT P1 WAS DETECTED. ALL OTHER VESSELS IN THE POSTERIOR CIRCULATION WERE NORMAL. FURTHER SPASM ON BOTH SITES OF THE A1 AND M1 SEGMENTS WERE PRESENT RESULTING IN PERFUSION DEFICITS IN THE RIGHT PERIPHERAL ANTERIOR AREA. NO OTHER ANEURYSM WAS NOTED. THE PATIENT MEDICAL HISTORY CONSISTED OF CURRENT SMOKER AND HAS NO OTHER KNOWN HISTORY. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE (B)(4) STUDY FOR SUBJECT (B)(6) THAT DURING PLACEMENT OF THE 4TH COIL (DELTAPAQ (B)(4)), LACERATION (RE-RUPTURING) WITH CONTRAST EXTRAVASATIONS AT THE DOME OF THE RUPTURED REGULAR ANEURYSM OF THE BASILAR TIP (RIGHT P1 SEGMENT ANEURYSM WAS NOTED. TWO COILS WHERE PLACED AND THE BLEEDING WAS STOPPED. NORMALLY HEPARIN IS USED DURING IN THIS KIND OF INTERVENTION, BUT DUE TO THIS EVENT NO HEPARIN WAS GIVEN. FINAL ANGIOGRAPHY SHOWED FULLY OCCLUDED ANEURYSM (RRGS 1), NORMAL PERIPHERAL VESSELS IN THE POSTERIOR CIRCULATION WITHOUT ANY EMBOLIC OCCLUSION. DYNA CT SHOWED HYPER DENSE CONTRAST MEDIA EXTRAVASATIONS IN THE SUBARACHNOID SPACE PERI-MESENCEPHALIC LEFT SIDE AS WELL IN THE CISTERN AMBIENS BOTH SIDES AND THE 4TH VENTRICLE. DUE TO THE CRITICAL PERFUSION OF THE ANTERIOR CIRCULATION THE SUBJECT RECEIVED AN INTRA ARTERIAL SPASMOLYSIS OF 10 ML NIMODIPINE. AFTERWARDS VASOSPASM DECREASED AND PERFUSION IN THE ANTERIOR CIRCULATION RETURNED TO NORMAL. DUE TO THE BLEEDING AND THE RISK OF DISTURBANCES IN CIRCULATION OF THE LIQUOR (CEREBROSPINAL FLUID) SUBJECT RECEIVED EXTERNAL VENTRICLE DRAINAGE. A TOTAL OF NINE MICROCOILS WERE IMPLANTED (MICRUSPHERE (B)(4), HELIPAQ - (B)(4), DELTAPAQ - (B)(4), DELTAPAQ - (B)(4), AND DELTAPLUSH (B)(4)). THE MEDICAL MONITOR INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE AND RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46929 MICRUSPHERE 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13702

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention