BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURPASS EVOLVE 4.0MM X 17MM - IDE

    MDR report key: 20169644 · Received September 9, 2024

    Report

    Report Number
    3008881809-2024-00403
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    July 13, 2023
    Report Date
    October 16, 2024
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    UDI-DI
    07613327387810
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - GTIN - CORRECTED FROM (B)(4) TO (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. ¿PARENT ARTERY STENOSIS AND IN-STENT STENOSIS >50 TO <=75%¿. 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¿

    Additional Manufacturer Narrative · 0

    THIS IS 1 OF 2 REPORTS (1ST MDR).

    Description of Event or Problem · 0

    CORE LAB DATA REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2022, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MIDDLE CEREBRAL ARTERY (M1 SEGMENT) ALONGSIDE A SECOND STENT. AT THE 12 MONTHS FOLLOW-UP ON (B)(6) 2023, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS AND IN-STENT STENOSIS OF >50% TO <=75%. 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 ON (B)(6) 2022, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MIDDLE CEREBRAL ARTERY (M1 SEGMENT) ALONGSIDE A SECOND STENT. AT THE 12 MONTHS FOLLOW-UP ON (B)(6) 2023, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS AND IN-STENT STENOSIS OF >50% TO <=75%. 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
    1601273 SURPASS EVOLVE 4.0MM X 17MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 22030091R 07613327387810

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other EVOLVE STENT (STRYKER)