BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 16841134 · Received April 29, 2023

    Report

    Report Number
    3005168196-2023-00208
    Event Type
    Injury
    Date Received
    April 29, 2023
    Date of Event
    April 1, 2015
    Report Date
    April 29, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 03-APR-2023, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "ENDOVASCULAR TREATMENT OF TANDEM ATHEROSCLEROTIC CERVICAL INTERNAL CAROTID ARTERY OCCLUSION IN THE SETTING OF ACUTE ISCHEMIC STROKE" (YAMASHITA ET AL. 2023). IN THIS SINGLE CENTER RETROSPECTIVE STUDY, TEN PATIENTS WERE TREATED FOR ATHEROSCLEROTIC CERVICAL INTERNAL CAROTID ARTERY OCCLUSION USING TWO DIFFERENT ENDOVASCULAR TREATMENT (EVT) METHODS FOLLOWED BY MECHANICAL THROMBECTOMY USING A PENUMBRA ASPIRATION CATHETER AND A STENT RETRIEVER (TREVO OR SOLITAIRE) BETWEEN APRIL 2015 AND MARCH 2018. ONE PATIENT UNDERWENT CAROTID ARTERY STENTING (CAS) FOLLOWED BY MECHANICAL THROMBECTOMY TO TREAT AN ATHEROSCLEROTIC CERVICAL INTERNAL CAROTID ARTERY OCCLUSION (ACICAO) AND A MIDDLE CEREBRAL ARTERY OCCLUSION (MCAO) WITH NO REPORTED PROCEDURAL COMPLICATIONS. A COMPUTED TOMOGRAPHY (CT) SCAN TAKEN IMMEDIATELY AFTER THE PROCEDURE SHOWED SUBARACHNOID HEMORRHAGE. TWO HOURS POST-PROCEDURE, ANOTHER CT SCAN WAS PERFORMED SHOWING MASSIVE INTRACRANIAL HEMORRHAGE (ICH). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND USE OF THE PENUMBRA ASPIRATION CATHETER WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737802 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other