BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS EVOLVE 4.5MM X 20MM - PMAS

    MDR report key: 20189875 · Received September 11, 2024

    Report

    Report Number
    3008881809-2024-00415
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 11, 2024
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    UDI-DI
    07613327375251
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF IMPLANT - D6A - ADDED. SUSPECT MEDICAL DEVICE - GTIN - D4 - CORRECTED FROM '(B)(4)'. PMA/510(K) - G4 - CORRECTED FROM 'P170024/S003' TO 'P170024'. DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT ' DURING A DIAGNOSTIC APPOINTMENT WHEN THE PATIENT CAME BACK, IT WAS NOTICED THAT THERE WAS MAL APPREHENSION ON PROXIMAL STENT'. NO SURGICAL DELAY AND NO MEDICAL INTERVENTION WERE REPORTED. THERE WAS AN ADVERSE CONSEQUENCE TO THE PATIENT, ¿90% FISH-MOUTHING WAS OBSERVED ON THE PROXIMAL END OF THE STENT DURING THE FOLLOW-UP¿. THE PATIENT WAS DISCHARGED HOME. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THIS COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITHIN THE DFU, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE AS REPORTED 'PATIENT PARENT VESSEL STENOSIS¿.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED DURING THE PROCEDURE AND IMPLANTATION AT FUSIFORM DISTAL ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING A FOLLOW-UP DIAGNOSTIC APPOINTMENT , MAL APPREHENSION (NARROWED AND NOT APPOSED) WAS OBSERVED IN THE SUBJECT'S PROXIMAL STENT. 90% FISH-MOUTHING WAS OBSERVED ON THE PROXIMAL END OF THE SUBJECT STENT DURING THE FOLLOW-UP NOT CAUSED BY HYPERPLASIA OR THROMBOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT FLOW DIVERTER PERFORMED AS INTENDED DURING THE PROCEDURE AND IMPLANTATION AT FUSIFORM DISTAL ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING A FOLLOW-UP DIAGNOSTIC APPOINTMENT, MAL APPREHENSION (NARROWED AND NOT APPOSED) WAS OBSERVED IN THE SUBJECT'S PROXIMAL STENT. 90% FISH-MOUTHING WAS OBSERVED ON THE PROXIMAL END OF THE SUBJECT STENT DURING THE FOLLOW-UP NOT CAUSED BY HYPERPLASIA OR THROMBOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612316 SURPASS EVOLVE 4.5MM X 20MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 23743056 07613327375251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other