BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 3MAX

    MDR report key: 3052913 · Received April 11, 2013

    Report

    Report Number
    3005168196-2013-00132
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 13, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: EMBOLI ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE 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. THIS CASE IS RELATED TO: 3005168196-2013-00130 AND 3005168196-2013-00133. DEVICE NOT SAVED FOR RETURN BY SITE.

    Description of Event or Problem · 1

    PATIENT WAS SUFFERING FROM ACUTE ISCHEMIC STROKE AND SHOWED EVIDENCE OF OCCLUSION IN THE LEFT M1 MCA. THE PATIENT WAS RANDOMIZED AND ENROLLED INTO THE (B)(4) TO TREATMENT WITH IV TPA WITH INTERVENTION WITH THE PENUMBRA SYSTEM. THE PATIENT WAS TREATED WITH THE SEPARATOR 3D DEVICE UNDER CONTINUOUS ASPIRATION WITH THE PSC054. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN EMBOLUS TO A NEW TERRITORY AND A PROCEDURAL VASOSPASM. THESE EVENTS WERE FIRST REPORTED ON (B)(4) 2013 BUT WERE CONFIRMED BY THE INVESTIGATOR ON (B)(4) 2013 WITH THE EMBOLUS HAVING PROBABLE RELATIONSHIP TO THE 3D AND PENUMBRA SYSTEM, AND THE VASOSPASM AS HAVING UNCLEAR/UNCERTAIN RELATIONSHIP TO THE 3D DEVICE/PENUMBRA SYSTEM. NO ACTION WAS TAKEN FOR THE EMBOLUS AND THE EVENT WAS GIVEN REMEDIAL THERAPY FOR THE VASOSPASM, WHICH WAS REPORTED AS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154698 PENUMBRA SYSTEM REPERFUSION CATHETER 3MAX NRY NRY PENUMBRA, INC. F26561

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening