BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA STROKE SYSTEM

    MDR report key: 1660209 · Received April 9, 2010

    Report

    Report Number
    3005168196-2010-00469
    Event Type
    Other
    Date Received
    April 9, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 1, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE HOSPITAL WITH A NIHSS 12. THE SITE OF OCCLUSION WAS IDENTIFIED AS THE LEFT M2 AND WAS ASSESSED AS A TIMI 0 PRIOR TO TREATMENT. THE VESSEL WAS REVASCULARIZED TO A TIMI 1 USING THE PENUMBRA SYSTEM AND 2MG IA-TPA. THE VESSEL WAS FURTHER OPENED TO A TIMI 2 WITH THE PENUMBRA SYSTEM AND THE PROCEDURE WAS ENDED. NO PROCEDURAL EVENTS WERE NOTED. DURING A POST-PROCEDURE CHECK A NURSE REPORTED A DETERIORATION IN THE PATIENT'S CLINICAL APPEARANCE TO THE NEUROLOGIST. THIS LED TO A REPEAT CT THAT DEMONSTRATED HEMORRHAGE IN THE REGION OF THE PATIENT'S PRIOR ISCHEMIA OF THE LEFT ANTERIOR MCA DISTRIBUTION, WITHOUT EVIDENCE OF SUBARACHNOID HEMORRHAGE. THE EVENT RESOLVED LESS THAN TWO WEEKS LATER. THE PHYSICIAN DETERMINED THAT THE EVENT WAS MODERATE AND POSSIBLY RELATED TO THE DEVICE AND THE ANGIOGRAPHIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA STROKE SYSTEM PERCUTANEOUS CATHETER DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR