BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 14599021 · Received June 3, 2022

    Report

    Report Number
    3005168196-2022-00257
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    November 1, 2016
    Report Date
    June 3, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, ACUTE OCCLUSION, EMBOLI, ARTERIOVENOUS FISTULA, VESSEL SPASM, VESSEL THROMBOSIS, VESSEL DISSECTION OR VESSEL PERFORATION, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED COMPLICATION. 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. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2022-00256, 3005168196-2022-00258, 3005168196-2022-00259, 3005168196-2022-00260, 3005168196-2022-00261.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 10-MAY-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "GUIDE SHEATH ADVANCEMENT AND ASPIRATION IN THE DISTAL PETROCAVERNOUS INTERNAL CAROTID ARTERY (GUARD) TECHNIQUE DURING THROMBECTOMY IMPROVES REPERFUSION AND CLINICAL OUTCOMES" (ANSARI ET AL. 2019). IN THIS RETROSPECTIVE CASE-CONTROL STUDY, NINETY PATIENTS WHO UNDERWENT THROMBECTOMY PROCEDURES BETWEEN NOVEMBER 2016 AND AUGUST 2018 WERE DIVIDED INTO TWO GROUPS BASED ON THROMBECTOMY TECHNIQUE. IN ALL CASES, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) OR NON-PENUMBRA GUIDE SHEATH WAS PLACED IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64), OR PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS USED TOGETHER WITH A NON-PENUMBRA MICROCATHETER AND OTHER DEVICES, AND ASPIRATION WAS PERFORMED USING THE PENUMBRA ENGINE (ENGINE). IN ONE CASE THAT MAY HAVE INVOLVED THE NEURON MAX, AN ICA DISSECTION OCCURRED FOLLOWING AGGRESSIVE GUIDE SHEATH ADVANCEMENT ACROSS THE POSTERIOR GENU SEGMENT OF THE CAVERNOUS ICA, WHICH WAS MEDICALLY TREATED WITH ASPIRIN AND WITHOUT NEUROLOGIC SEQUELAE. IN ANOTHER CASE THAT MAY HAVE INVOLVED THE NEURON MAX, A SUSPECTED IATROGENIC, NON-FLOW-LIMITING INTRACRANIAL MCA DISSECTION OCCURRED AND WAS MANAGED MEDICALLY WITH IV EPTIFIBATIDE AND POST-PROCEDURAL ANTIPLATELETS. THE SAME ISSUE OCCURRED IN TWO CASES WHICH INVOLVED THE USE OF THE ACE60, ACE64, OR ACE68. THESE CASES WERE ALSO MANAGED MEDICALLY WITH IV EPTIFIBATIDE AND POST-PROCEDURAL ANTIPLATELETS. IT WAS REPORTED THAT MAJOR IATROGENIC COMPLICATIONS OCCURRED IN TWO CASES WHICH INVOLVED THE USE OF THE ACE60, ACE64, OR ACE68. NEW TERRITORY EMBOLI WERE VISUALIZED IN THE FETAL POSTERIOR CEREBRAL ARTERY DISTRIBUTION AND A SECONDARY INTRAPROCEDURAL OCCLUSION OF THE CONTRALATERAL ICA, RESPECTIVELY. LASTLY, IN FIVE CASES THAT MAY HAVE INVOLVED THE NEURON MAX, MINOR ACCESS-SITE COMPLICATIONS INCLUDED A GROIN PSEUDOANEURYSM REQUIRING PERCUTANEOUS THROMBIN INJECTION, A CAROTID PUNCTURE-RELATED PSEUDOANEURYSM TREATED WITH SONOGRAPHY-GUIDED COMPRESSION, AND THREE MINOR GROIN HEMATOMAS THAT WERE MANAGED CONSERVATIVELY. 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
    306554 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention