BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER

    MDR report key: 11681590 · Received April 16, 2021

    Report

    Report Number
    3005168196-2021-00771
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    January 1, 2016
    Report Date
    March 19, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. 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, DISSECTION, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, VESSEL SPASM, THROMBOSIS, ISCHEMIA, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2021, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "IATROGENIC INTRACRANIAL VESSEL DISSECTION DURING MECHANICAL THROMBECTOMY RESCUED BY EMERGENT STENTING: 2 CASE REPORTS. RADIOLOGY CASE REPORTS." (NAKAHARA ET AL. 2021). THIS ARTICLE REPORTS TWO CASES OF IATROGENIC INTRACRANIAL DISSECTION OUT OF A COHORT OF TWO-HUNDRED AND FIFTY MECHANICAL THROMBECTOMY CASES FROM A SINGLE CENTER TAKING PLACE BETWEEN JANUARY 2016 AND JANUARY 2021. IN ONE CASE, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). IT WAS REPORTED THAT, "WHEN THE MICROCATHETER WAS REMOVED TO INCREASE SUCTION FORCE FROM THE PENUMBRA, THE PENUMBRA UNINTENTIONALLY SHIFTED UP TO THE MID-M1 WHICH WAS INITIALLY NONOCCLUDED BUT MILDLY ARTERIOSCLEROTIC." IT WAS DETERMINED THAT, "BASED ON THE IRREGULAR STENOSIS AND THE PRECEDING MANEUVER, THIS LESION WAS CONSIDERED A VESSEL DISSECTION INDUCED BY THE TIP OF THE PENUMBRA CATHETER AT AN INITIALLY ATHEROSCLEROTIC VESSEL." 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
    578941 PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other