BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER

    MDR report key: 14164343 · Received April 20, 2022

    Report

    Report Number
    3005168196-2022-00184
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    January 1, 2018
    Report Date
    April 20, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K161640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, DISTAL EMBOLIZATION, EMBOLI, 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, "COMPARISON OF ASPIRATION-FIRST VERSUS STENTRIEVER-FIRST TECHNIQUES IN PERFORMING MECHANICAL THROMBECTOMY FOR LARGE VESSEL OCCLUSIONS" (FREDRICKSON ET AL. 2020). IN THIS RETROSPECTIVE REVIEW, TWENTY PATIENTS WERE TREATED WITH ASPIRATION FIRST USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY) BETWEEN 01-JAN-2018 TO 31-DEC-2018. IT WAS REPORTED THAT THE INITIAL ATTEMPT AT ASPIRATION WITH THE ACE68 FAILED TO REMOVE THE CLOT IN THREE CASES. THEREFORE, A STENT RETRIEVER WAS USED. SEVEN CASES OF EMBOLUS IN NEW ARTERIAL TERRITORY WERE REPORTED IN PROCEDURES INVOLVING THE ACE68. HOWEVER, THE RELATIONSHIP BETWEEN THE ACE68 AND THE EMBOLUS IN NEW ARTERIAL TERRITORY WERE NOT SPECIFIED. 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
    2326512 PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other