BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 15366292 · Received September 6, 2022

    Report

    Report Number
    3005168196-2022-00408
    Event Type
    Death
    Date Received
    September 6, 2022
    Date of Event
    September 1, 2015
    Report Date
    September 6, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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. THROMBOSIS, DISTAL EMBOLIZATION AND DEATH ARE INCLUDED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 12-AUG-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, ¿TRANSCIRCULATION APPROACH FOR MECHANICAL THROMBECTOMY IN ACUTE ISCHEMIC STROKE: A MULTICENTER STUDY AND REVIEW OF THE LITERATURE" (ROA ET AL. 2020). IN THIS MULTICENTER RETROSPECTIVE REVIEW, FOUR PATIENTS WITH ACUTE ISCHEMIC STROKE (AIS) UNDERWENT MECHANICAL THROMBECTOMY PROCEDURES VIA A TRANSCIRCULATION APPROACH USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) BETWEEN SEPTEMBER 2015 AND APRIL 2019. ONE ARTERIAL THROMBUS TO ANOTHER VASCULAR TERRITORY WAS REPORTED IN A PATIENT WITH A RIGHT MIDDLE CEREBRAL ARTERY (MCA) STROKE THAT WAS FULLY RECANALIZED (TICI 3) VIA THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING THE 3MAXC, LEADING TO A BRAINSTEM INFARCT DUE TO OCCLUSION OF THE BASILAR ARTERY (BA). THIS PATIENT EXPIRED FROM THE LARGE STROKE BURDEN DESPITE SUCCESSFUL RECANALIZATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2683518 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Male Death