BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 18907485 · Received March 14, 2024

    Report

    Report Number
    3014590708-2024-00012
    Event Type
    Death
    Date Received
    March 14, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 14, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 71. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. THE EXACT ROOT CAUSE OF THE VESSEL DISSECTION AND SUBARACHNOID HEMORRHAGE (SAH) IS UNKNOWN. IT WAS REPORTED THAT AFTER THE MICROWIRE AND MICROCATHETER WERE ADVANCED ACROSS THE CLOT, RESISTANCE WAS LATER FELT WHILE TRYING TO ADVANCE THE ZOOM 71 TO THE FACE OF THE CLOT. BASED ON THE LOCATION OF THE DEVICES PROVIDED AND WITH LIMITED CASE IMAGES, IT IS UNCLEAR IF THE EVENTS WERE CAUSED BY THE ZOOM 71, THE MICROWIRE, STENT RETRIEVER OR THE THIRD-PARTY MICROCATHETER.

    Additional Manufacturer Narrative · 0

    DATE OF PATIENT'S PASSING WAS INCLUDED AND APPROPRIATE FIELDS WERE UPDATED.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE RIGHT M1 SEGMENT. ACCESS WAS OBTAINED WITH A THIRD-PARTY GUIDE CATHETER, THIRD-PARTY 5F CATHETER, AND A GUIDEWIRE. THE GUIDE CATHETER WAS POSITIONED AT THE HIGH CERVICAL OF THE INTERNAL CAROTID ARTERY (ICA) AND THE GUIDEWIRE WAS REMOVED. A MICROWIRE, THIRD-PARTY MICROCATHETER, AND ZOOM 71 ASPIRATION CATHETER, WERE ADVANCED TO THE CLOT, AND A STENT RETRIEVER WAS DEPLOYED USING A SOLUMBRA TECHNIQUE. DURING THE FIRST PASS, A PORTION OF THE CLOT WAS REMOVED. NO ISSUES WERE REPORTED DURING THE FIRST PASS. DURING THE SECOND PASS, THE SAME DEVICES AND SAME APPROACH WERE USED. THE MICROWIRE AND THIRD-PARTY MICROCATHETER WERE ADVANCED ACROSS THE CLOT. WHILE ADVANCING THE ZOOM 71 TO THE FACE OF THE CLOT THE PHYSICIAN REPORTED FEELING RESISTANCE. THE MICROWIRE WAS REMOVED AND A STENT RETRIEVER WAS DEPLOYED THROUGH THE THIRD-PARTY MICROCATHETER. THE THIRD-PARTY MICROCATHETER WAS REMOVED, AND THE STENT RETRIEVER WAS ALLOWED TO DWELL FOR 2-4 MINUTES. THE STENT RETRIEVER AND ZOOM 71 WERE WITHDRAWN WHILE ASPIRATION WAS APPLIED TO THE ZOOM 71. AFTER THE DEVICES WERE REMOVED, A CONTRAST RUN WAS PERFORMED THROUGH THE THIRD-PARTY GUIDE CATHETER, REVEALING A VESSEL DISSECTION IN THE MID PART OF THE MIDDLE CEREBRAL ARTERY (MCA) AND A SUBARACHNOID HEMORRHAGE (SAH) DISTAL TO THE DISSECTION. THE PHYSICIAN PREPARED BALLOONS TO TREAT THE DISSECTION AND SAH. HOWEVER, BOTH BALLOONS MALFUNCTIONED DURING PREPARATION. ANOTHER CONTRAST RUN WAS PERFORMED, AND IMAGING SHOWED THAT THE MCA HAD CLOSED. NO FURTHER PASSES WERE ATTEMPTED, AND NO TICI SCORE WAS ASSIGNED. THERE WAS NO REPORTED DEVICE MALFUNCTION. IN RELATION TO THE DISSECTION AND SAH, IT WAS REPORTED THAT THE ZOOM 71 WAS IN THE MCA, THE THIRD-PARTY GUIDE CATHETER WAS IN THE CERVICAL ICA, AND THE MICROWIRE, THIRD-PARTY MICROCATHETER, AND STENT RETRIEVER WERE ALL THROUGH THE DISSECTION AND DISTAL TO IT. THE TREATING PHYSICIAN REPORTED THAT THE ZOOM 71 DEVICE WAS RELATED TO THE VESSEL DISSECTION AND SAH. FOUR DAYS POST-PROCEDURE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS ATTRIBUTED TO THE STROKE AND HEMORRHAGE.

    Description of Event or Problem · 0

    REFER TO H10 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956645 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2327201 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Life Threatening| D 0.035" GLIDEWIRE| INFINITY GUIDE CATHETER| PENUMBRA 5F SIM SELECT CATHETER| SYNCHRO GUIDEWIRE| TREVO STENT RETRIEVER| VELOCITY MICROCATHETER