BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 14164758 · Received April 20, 2022

    Report

    Report Number
    3005168196-2022-00185
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    January 1, 2016
    Report Date
    April 20, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. POTENTIAL ADVERSE EVENTS IN THE PENUMBRA SYSTEM INSTRUCTIONS FOR USE (IFU) INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT ACCESS SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. 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 (B)(6) 2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "EFFECTIVENESS AND SAFETY OF ICA STENTING IN CONJUNCTION WITH MECHANICAL THROMBECTOMY (ANTEGRADE APPROACH) IN ACUTE ISCHAEMIC STROKE PATIENTS DUE TO TANDEM OCCLUSION" (SOJKA ET AL. 2020). IN THIS PROSPECTIVE SINGLE CENTER STUDY, THIRTY-FOUR PATIENTS WERE DIAGNOSED AND TREATED FOR ISCHEMIC STROKE BETWEEN JANUARY 2016 AND MAY 2019 USING A PENUMBRA SYSTEM REPERFUSION CATHETER TO PERFORM MECHANICAL THROMBECTOMY. IT WAS REPORTED THAT FOUR CASES OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) OCCURRED. HOWEVER, NO PROCEDURAL COMPLICATIONS WERE REPORTED WITH ANY PENUMBRA SYSTEM REPERFUSION CATHETER. 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
    1713556 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other