BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURPASS EVOLVE 3.25MM X 15MM - IDE

    MDR report key: 20153146 · Received September 5, 2024

    Report

    Report Number
    3008881809-2024-00405
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    March 17, 2023
    Report Date
    October 16, 2024
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    UDI-DI
    07613327374735
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4 MANUFACTURING DATE ¿ ADDED D4 EXPIRATION DATE - ADDED D4 - GTIN - CORRECTED (B)(4). PMA/510(K) - G4 - CORRECTED FROM 'P170024/S003' TO 'P170024'. B3 - EVENT DATE - CORRECTED. DATE OF IMPLANT - D6A - ADDED. 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 STATES "THE FLOW DIVERTER DOES NOT APPEAR TO BE PROPERLY WALL ADAPTED WITH SMALL GAPS BETWEEN THE STENT AND INNER WALL, LIKELY FD UNDERSIZED'. ADDITIONAL INFORMATION INDICATED THE STENT WAS DEPLOYED SUCCESSFULLY DURING PROCEDURE AND THE IMPLANTED STENT COMPLETELY COVERED ANEURYSM NECK. WHILE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED, IT IS MOST LIKELY THAT ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE RESULTED IN THE STENT DISLODGE/MIGRATED. THE FLOW DIVERTER MAY HAVE BEEN UNDERSIZED CAUSING THE STENT TO BECOME DISLODGED/MIGRATED. AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE AS REPORTED ¿STENT DISLODGED/MIGRATED¿ AS THE PRODUCT WAS NOT RETURNED, AND REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE.

    Description of Event or Problem · 0

    BASED ON CORE LAB DATA, IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL PROCEDURE, PROCEDURAL DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING INDICATED THAT THE SUBJECT FLOW DIVERTER DID NOT APPEAR TO BE PROPERLY WALL-ADAPTED, WITH SMALL GAPS BETWEEN THE STENT AND THE VESSEL WALL, LIKELY DUE TO UNDER SIZING. AT THE 12-MONTH FOLLOW-UP, DSA IMAGING SHOWED THAT THE SUBJECT FLOW DIVERTER HAD MIGRATED (2MM, ANEURYSM IS STILL COVERED). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    BASED ON CORE LAB DATA, IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL PROCEDURE, PROCEDURAL DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING INDICATED THAT THE SUBJECT FLOW DIVERTER DID NOT APPEAR TO BE PROPERLY WALL-ADAPTED, WITH SMALL GAPS BETWEEN THE STENT AND THE VESSEL WALL, LIKELY DUE TO UNDER SIZING. AT THE 12-MONTH FOLLOW-UP, DSA IMAGING SHOWED THAT THE SUBJECT FLOW DIVERTER HAD MIGRATED (2MM, ANEURYSM IS STILL COVERED). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235284 SURPASS EVOLVE 3.25MM X 15MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 22164253R 07613327374735

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female