BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 21869144 · Received April 18, 2025

    Report

    Report Number
    3005168196-2025-00126
    Event Type
    Death
    Date Received
    April 18, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 18, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00815948022393
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WITH SOME DIFFICULTY, THE NEURON MAX WAS ADVANCED THROUGH A STENT AT THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. UPON REMOVAL OF THE NEURON MAX 6F SELECT INNER CATHETER, THE NEURON MAX DISTAL TIP WAS FOUND TO BE FRACTURED. CONTRAST INJECTION DEMONSTRATED MINIMAL FLOW INTO THE LEFT MIDDLE CEREBRAL ARTERY AS WELL AS THE LEFT ANTERIOR CEREBRAL ARTERY DUE TO THE FRACTURED NEURON MAX SEGMENT. ATTEMPTS TO RETRIEVE THE NEURON MAX FRACTURED SEGMENT WERE UNSUCCESSFUL FOLLOWED BY GROSS SUBARACHNOID HEMORRHAGE. SUBSEQUENT COIL OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY WAS PERFORMED TO CONTROL BLEEDING. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. POST-PROCEDURE, THE PATIENT REMAINED INTUBATED, NOT SEDATED, REQUIRING FOUR VASOPRESSORS. THE PATIENT HAD NO COUGH, GAG, OR CORNEAL REFLEX. PUPILS WERE 7MM AND NONREACTIVE BILATERALLY. DISCUSSION WITH THE SPOUSE/FAMILY GIVEN HEMODYNAMIC INSTABILITY AND UNLIKELY MEANINGFUL OUTCOME. THE FAMILY DECIDED TO TRANSITION TO COMFORT CARE, AND THE PATIENT EXPIRED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20461 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. H00006653 00815948022393

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death