BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE

    MDR report key: 17243874 · Received June 30, 2023

    Report

    Report Number
    3008881809-2023-00327
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 14, 2023
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    P180031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    SECTION B1 PRODUCT PROBLEM - CORRECTED - NO PRODUCT PROBLEM B5 - EXECUTIVE SUMMARY - UPDATED SECTION H1 TYPE OF REPORTABLE EVENT - CORRECTED - NO MALFUNCTION F10 / H6 DEVICE CODE GRID - UPDATED H6 CONCLUSION CODE GRID - UPDATED THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH SUBARACHNOID HEMORRHAGE SAH WITH PCOMA WIDE-NECK ANEURYSM, RESISTANCE BECAME BIGGER WHEN DELIVERED THE SUBJECT STENT TO GO INTO THE MICROCATHETER AND THE STENT COULD NOT BE ADVANCED INTO MICROCATHETER. CHECKED IT AND FOUND THE SUBJECT STENT DETACHED FROM DELIVERY WIRE AND STUCK AT PROXIMAL OF MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT WITH SUB ARACHNOID HEMORRHAGE SAH WITH PCOMA WIDE-NECK ANEURYSM, RESISTANCE BECAME BIGGER WHEN DELIVERED THE SUBJECT STENT TO GO INTO THE MICROCATHETER AND THE STENT COULD NOT BE ADVANCED INTO MICROCATHETER. CHECKED IT AND FOUND THE SUBJECT STENT DETACHED FROM DELIVERY WIRE AND STUCK AT PROXIMAL OF MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. UPDATE ADDITIONAL INFORMATION RECEIVED ON 12-JUL-2023 STATED THAT THE SUBJECT STENT WAS DETACHED IN THE MICROCATHETER'S HUB (OUTSIDE PATIENT). NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22571 NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 22510740

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female 6F GUIDE CATHETER (UNKNOWN).| SL10 MICROCATHETER (STRYKER).| SYNCHRO GUIDEWIRE (STRYKER).