BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 13676170 · Received March 4, 2022

    Report

    Report Number
    3005168196-2022-00105
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    January 1, 2014
    Report Date
    March 4, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K161640. 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, DISTAL EMBOLIZATION, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, VESSEL SPASM, THROMBOSIS, DISSECTION, ISCHEMIA, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00104.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 04-FEB-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "STENT-RETRIEVER ASSISTED VACUUM-LOCKED EXTRACTION (SAVE) VERSUS A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) FOR ACUTE STROKE: DATA FROM THE REAL-WORLD" (BREHM ET AL. 2019). THIS ARTICLE ANALYZES THE EFFECTIVENESS OF THE ADAPT AND SAVE TECHNIQUES IN TREATING ONE-HUNDRED AND SEVENTY-ONE PATIENTS SUFFERING FROM ACUTE ISCHEMIC STROKE (AIS) CAUSED BY LARGE VESSEL OCCLUSION (LVO) IN THE ANTERIOR CIRCULATION (CAROTID T, M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA)) BETWEEN JANUARY 2014 AND SEPTEMBER 2017. IT WAS REPORTED THAT THE FOLLOWING PENUMBRA DEVICES WERE USED IN SELECT PROCEDURES: A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64). HOWEVER, THERE WAS NOT ENOUGH INFORMATION TO DETERMINE HOW THE PENUMBRA SYSTEM REPERFUSION CATHETERS WERE BEING UTILIZED AND WHETHER THE PENUMBRA SYSTEM REPERFUSION CATHETERS WERE INVOLVED IN THE REPORTED EVENTS. IT WAS REPORTED THAT THE FOLLOWING SECONDARY OUTCOMES OCCURRED, ¿ENTS (EMBOLI IN NEW TERRITORY) OCCURRED IN 9% OF THE ADAPT STUDY POPULATION AND 3% OF THE SAVE STUDY POPULATION¿ AND ¿SICH (SYMPTOMATIC INTRACRANIAL HEMORRHAGE) OCCURRED IN 3% OF THE ADAPT STUDY POPULATION AND 5% OF THE SAVE STUDY POPULATION)¿. 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
    1532363 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown