BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19779103 · Received July 18, 2024

    Report

    Report Number
    3014590708-2024-00023
    Event Type
    Death
    Date Received
    July 18, 2024
    Date of Event
    September 24, 2022
    Report Date
    July 18, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 88 OR ZOOM 71. BASED ON THE INFORMATION PROVIDED AND WITHOUT CASE IMAGES, THE EXACT CAUSE FOR THE RECURRENT STROKE IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD ACHIEVED COMPLETE REPERFUSION AFTER THE FIRST THROMBECTOMY PROCEDURE. THE RELATIONSHIP WITH THE ZOOM DEVICES TO THE RECURRENT STROKE COULD NOT BE ESTABLISHED. IT IS UNCLEAR IF THE RECURRENT STROKE WAS CAUSED BY THE ZOOM DEVICES, THE STENT RETRIEVER, OR THE HYPERCOAGULABLE CONDITION THE PATIENT WAS FOUND TO LATER HAVE. THE MANUFACTURING RECORDS FOR THE ZOOM DEVICES WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. THE FOLLOWING MFR # WERE SUBMITTED: MFR # 3013590708-2024-00022 FOR ZOOM 88; MFR # FOR ZOOM 71.

    Description of Event or Problem · 0

    A 67-YEAR-OLD MALE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE LEFT M1 SEGMENT. A ZOOM 88 ACCESS CATHETER AND A THIRD-PARTY INSERT CATHETER WERE INTRODUCED INTO THE LEFT COMMON CAROTID ARTERY (CCA) AS A SYSTEM. A ROADMAP ANGIOGRAM WAS COMPLETED OF THE CCA TO VISUALIZE THE CAROTID BIFURCATION. A DIAGNOSTIC CATHETER WAS USED TO SELECT THE INTERNAL CAROTID ARTERY (ICA) OVER A GLIDEWIRE. THE ZOOM 88 WAS THEN ADVANCED AND PARKED AT THE ICA CAVERNOUS. DURING THE FIRST AND SECOND PASSES, A THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH A ZOOM 71 ASPIRATION CATHETER AS A SYSTEM INTO THE ZOOM 88. THE ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. THE ZOOM 71 CATHETER WAS REMOVED UNDER CONTINUOUS ASPIRATION FROM THE PATIENT. A CONTRAST RUN SHOWED THE THROMBUS WAS NOT ASPIRATED. DURING THE THIRD PASS, A DIFFERENT THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH THE ZOOM 88 PAST THE M1 OCCLUSION. THE MICROWIRE WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A STENT RETRIEVER. THE STENT RETRIEVER WAS ADVANCED AND ALLOWED TO SET IN THE CLOT FOR 5 MINUTES. THE STENT RETRIEVER WAS REMOVED; HOWEVER, THE THROMBUS WAS NOT CAPTURED WITHIN THE STENT RETRIEVER. FOR THE FOURTH PASS, THE SAME THIRD-PARTY MICROCATHETER AND MICROWIRE USED IN THE THIRD PASS WERE AGAIN ADVANCED THROUGH THE ZOOM 88 PAST THE M1 OCCLUSION. THE MICROWIRE WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH THE SAME STENT RETRIEVER. THE STENT RETRIEVER WAS DEPLOYED AND AGAIN SET IN THE CLOT FOR 5 MINUTES. THE STENT RETRIEVER WAS REMOVED, AND THE THROMBUS WAS CAPTURED WITHIN THE STENT RETRIEVER. AN ANGIOGRAM WAS PERFORMED AND RECANALIZATION OF THE LEFT M1 DISTRIBUTION WAS ACHIEVED WITH A TICI 3 SCORE. NO DEVICE ISSUES WERE REPORTED. ONE WEEK POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ALTERED MENTAL STATUS. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED A NEW OCCLUSION AT THE LEFT M2 SEGMENT. THE PATIENT RECEIVED A SECOND MECHANICAL INTERVENTION, AND THE RECURRENT STROKE WAS RESOLVED WITH TICI 3 REPERFUSION. NO PROCEDURE OR DEVICE INFORMATION WAS PROVIDED. THREE WEEKS AFTER THE SECOND THROMBECTOMY PROCEDURE, THE PATIENT WAS DISCHARGED HOME. ONE MONTH AFTER DISCHARGE, IT WAS NOTED THAT THE PATIENT DEVELOPED A HYPERCOAGULABLE CONDITION, WHICH LED TO HIS PASSING APPROXIMATELY TEN DAYS LATER. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS HYPERCOAGULABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500613 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2219901 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| O ARISTOTLE 18 MICROWIRE| ASAHI CHIKAI GUIDE WIRE| MARKSMAN MICROCATHETER| SOLITAIRE STENT RETRIEVER| TREVO TRAK21 MICROCATHETER| ZOOM 71