BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS EVOLVE 3.25MM X 12MM - IDE

    MDR report key: 20157436 · Received September 6, 2024

    Report

    Report Number
    3008881809-2024-00407
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    April 4, 2023
    Report Date
    October 16, 2024
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    UDI-DI
    07613327387681
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4: MANUFACTURING DATE: ADDED. D4: EXPIRATION DATE: ADDED. D4: GTIN - 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 INDICATED THAT THERE WAS AN ADVERSE CONSEQUENCE TO THE PATIENT. ¿IN-STENT STENOSIS AND PARENT ARTERY STENOSIS >75 TO 100% BASED ON CORE LAB AT 12M FOLLOW-UP¿. THERE WAS NO SURGICAL DELAY, AND NO MEDICAL INTERVENTION REPORTED. NO DEVICE DEFICIENCY WAS REPORTED. 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 REPORTED EVENT 'PATIENT PARENT VESSEL STENOSIS.'

    Description of Event or Problem · 0

    CORE LAB DATA REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED AT RIGHT MIDDLE CEREBRAL ARTERY (M1 SEGMENT). AT THE 12-MONTH FOLLOW-UP, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS >75-100% WITH INTIMAL HYPERPLASIA. THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE SUBJECT DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    CORE LAB DATA REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED AT RIGHT MIDDLE CEREBRAL ARTERY (M1 SEGMENT). AT THE 12-MONTH FOLLOW-UP, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS >75-100% WITH INTIMAL HYPERPLASIA. THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE SUBJECT DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073186 SURPASS EVOLVE 3.25MM X 12MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 22111959R 07613327387681

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other