BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 1899125 · Received October 26, 2010

    Report

    Report Number
    3005168196-2010-00654
    Event Type
    Other
    Date Received
    October 26, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 28, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VESSEL OCCLUSION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THE INFO IN THIS REPORT WAS COLLECTED DURING THE (B)(4) CLINICAL TRIAL. THERE WERE A NUMBER OF DEVICES USED DURING THE CASE AND NO ONE DEVICE COULD BE IDENTIFIED AS THE EXACT CAUSE OF THE EVENT. THEREFORE, AN MDR WILL BE SUBMITTED FOR EACH OF THE PENUMBRA DEVICES POSSIBLY INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED FOR AN OCCLUSION OF THE RIGHT MCA WHICH WAS DETERMINED TO BE CARDIOEMBOLIC. THE PT WAS TREATED WITH SEVERAL MILLIGRAMS OF TPA. ATTEMPTS WERE MADE TO FIND THE ORIGIN OF THE SUPERIOR DIVISION OF THE MCA THROUGH THE LATERAL M1 SEGMENT. THE FRONTAL POLAR BRANCH OF THE MCA WAS BRIEFLY ACCESSED. FOLLOWING THESE ATTEMPTS USING THE PENUMBRA SYSTEM 054 AND 032, WHICH WERE ULTIMATELY UNSUCCESSFUL, AN ANGIOGRAM DEMONSTRATED COMPLETE REOCCLUSION OF THE M1 SEGMENT. THE PENUMBRA SYSTEM 041 WAS USED TO TREAT THE REOCCLUSION WHICH RECANALIZED THE M1 SEGMENT AGAIN WITH REMAINING NARROWING AT THE M1/M2 JUNCTION BUT WITH GOOD ANTEGRADE FLOW AND FILLING OF THE POSTERIOR DIVISION. THE EVENT WAS DETERMINED TO BE OF AN "UNCERTAIN" RELATIONSHIP TO THE STUDY DEVICE AND "POSSIBLY" RELATED TO THE ANGIOGRAPHIC PROCEDURE. THE REOCCLUSION WAS CLASSIFIED AS HAVING MODERATE SEVERITY AND WAS ULTIMATELY RESOLVED. THIS MDR IS ASSOCIATED WITH MDR'S 3005168196-2010-00655, 3005168196-2010-00656, 3005168196-2010-00657, AND 3005168196-2010-00658.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 PERCUTANEOUS CATHETER NRY PENUMBRA INC. F16354

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention