BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 041/026

    MDR report key: 1654499 · Received April 7, 2010

    Report

    Report Number
    3005168196-2010-00467
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    May 18, 2009
    Report Date
    May 19, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATRIAL FIBRILLATION WAS RECORDED ON THE STUDY ADVERSE EVENT FORM AS BEING "POSSIBLY" RELATED TO THE STUDY DEVICE AND/OR ANGIOGRAPHIC PROCEDURE. HOWEVER, THE SERIOUS ADVERSE EVENT FORM STATES THAT THE SITE IS "UNCERTAIN" WHETHER THE EVENT WAS CAUSED BY THE STUDY DEVICE AND/OR PROCEDURE. FOLLOW-UP WITH THE SITE PHYSICIAN COULD NOT RULE OUT DEVICE RELATIONSHIP BECAUSE THE ATRIAL FIBRILLATION OCCURRED SOON AFTER THE PROCEDURE. THE ATRIAL FIBRILLATION WAS BELIEVED TO HAVE BEEN CHRONIC HOWEVER, NEVER DOCUMENTED PRIOR TO THE EVENT. THE PATIENT WAS STARTED ON COUMADIN. THE ATRIAL FIBRILLATION WAS REPORTED AS CONTINUING AT STUDY COMPLETION (90 DAYS POST-PROCEDURE). DURING THE 90-DAY FOLLOW-UP ASSESSMENT, THE MODIFIED (B) (6) SCALE SCORE WAS REPORTED TO BE 0 (NO SYMPTOMS). THIS EVENT IS BEING REPORTED AS A MEDICAL DEVICE REPORT BECAUSE ITS POSSIBLE AND UNCERTAIN RELATIONSHIP TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH AN OCCLUSION OF THE LEFT ICA SUPRACLINOID. ONE DAY POST-PROCEDURE, THE PATIENT WAS IN NSICU ON TELEMETRY WHEN THEY WERE NOTED TO GO IN AND OUT OF ATRIAL FIBRILLATION. ATRIAL FIBRILLATION WAS BELIEVED TO HAVE BEEN CHRONIC; HOWEVER, IT WAS NEVER DOCUMENTED PRIOR TO THIS EVENT. THE OPERATIVE REPORT STATED THAT THERE WAS INITIAL DIFFICULTY ADVANCING A PSC041 AND THEREFORE, A MICROCATHETER WAS ADVANCED INTO THE ICA. THE PSC041 WAS REINTRODUCED WITH AND A SINGLE ASPIRATION PASS WAS MADE. A CONTROL ANGIOGRAM REVEALED A TIMI3 FLOW WITHIN THE TERMINAL ICA, LEFT ANTERIOR CEREBRAL ARTERY, M1 SEGMENT OF THE MCA AND PCA. AN EMBOLUS WAS NOTED WITHIN THE ORIGIN OF THE SUPERIOR DIVISION OF THE M2 BRANCH AND EVIDENCE OF FRAGMENTATION AND EMBOLIZATION OF THE PCA. CLOT COMPONENT WITH DISTAL RIGHT PCA OCCLUSION. A PSC026 WAS ADVANCED INTO THE SUPERIOR DIVISION OF THE M2 AND 3MG R-TPA WERE INJECTED INTO THE CLOT. A PASS WAS MADE USING THE PENUMBRA SYSTEM AND A SECOND CONTROL ANGIOGRAM WAS TAKEN. THE ANGIOGRAM DEMONSTRATED CONTINUED SIGNIFICANT STENOSIS SECONDARY TO RESIDUAL CLOT. AN ADDITIONAL PASS WAS MADE WITH THE 026 SYSTEM. THE ANGIOGRAM SHOWED NEAR TOTAL RESOLUTION OF THE CLOT. THERE WAS EVIDENCE OF PERIPHERAL M4 OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM 041/026 NONE NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening