BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 17240188 · Received June 30, 2023

    Report

    Report Number
    3005168196-2023-00306
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 1, 2018
    Report Date
    June 30, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. INTRACRANIAL HEMORRHAGE IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    ON 09-JUN-2023, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "THE EVALUATION AND TREATMENT OF ACUTE ANTERIOR CIRCULATION OCCLUSION STROKE WITH HIGH CLOT BURDEN: PROGRESSIVE STRATIFIED ASPIRATION THROMBECTOMY VS. STENT RETRIEVER THROMBECTOMY" (HUANG ET AL. 2023). IN THIS SINGLE CENTER RETROSPECTIVE STUDY, SIXTY-FIVE PATIENTS WITH ACUTE ISCHEMIC STROKE AND LARGE VESSEL OCCLUSION (AIS-LVO) WERE TREATED BETWEEN JUNE 2018 AND JUNE 2021. IF THE THROMBUS WAS AT THE END OF THE INTERNAL CAROTID ARTERY (ICA) OR IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) OR A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS USED. IF THE THROMBUS WAS IN THE M1 AND M2 SEGMENTS OF THE MCA, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) OR A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) WAS USED.IT WAS REPORTED THAT FIFTEEN PATIENTS EXPERIENCED SYMPTOMATIC INTRACRANIAL HEMORRHAGES (SICH) SEVEN DAYS POST-PROCEDURE. HOWEVER, THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS AND THE RELATIONSHIP BETWEEN A SICH AND PENUMBRA REPERFUSION CATHETER WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343834 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other