BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRED 27

    MDR report key: 17052623 · Received June 2, 2023

    Report

    Report Number
    2032493-2023-00763
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    February 9, 2023
    Report Date
    May 19, 2023
    Manufacturer
    MICROVENTION INC.
    Product Code
    OUT
    UDI-DI
    04987892121906
    PMA / PMN Number
    P180027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: THE INVESTIGATION FOUND THE STENT RETURNED FULLY DEPLOYED AND SUSPENDED IN A TUBE FILLED WITH UNKNOWN LIQUID. THE STENT WAS ABLE TO FULLY OPEN UPON DEPLOYMENT THROUGH THE RETURNED MICROCATHETER DURING FUNCTIONAL TESTING. THE INVESTIGATION OF THE PHYSICAL DEVICES DID NOT FIND ANY DAMAGE OR OTHER ANOMALY THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. P23-0805 SLIDESHOW FROM CUSTOMER: IMAGE REVIEW: AP AND LATERAL LEFT ICA SINGLE SHOT UNSUBTRACTED IMAGES WITH SOME CONTRAST DURING DEPLOYMENT OF THE FRED. THE FRED IS ABOUT 25% DEPLOYED AND THESE IMAGES LOOK NORMAL FOR A FRED AT THIS STAGE OF DEPLOYMENT. THE DISTAL END OF THE FRED IS IN THE PROXIMAL M1 SEGMENT OF THE LEFT MCA. AP AND LATERAL LEFT ICA SUBTRACTED DSA WITH CONTRAST. THE FRED IS 90% DEPLOYED. AS THESE IMAGES ARE SUBTRACTED, THE STATE OF ITS OPENING CANNOT BE DETERMINED. THE FRED IS ALMOST OCCLUDED/THROMBOSED AT ITS DISTAL END, WITH MINIMAL CONTRAST PASSING TO THE LEFT MCA. AN APPROXIMATELY 5-8 MM PCOM ANEURYSM IS DEMONSTRATED. PHOTOGRAPH OF THE STENT/MICROCATHETER AFTER REMOVAL: THE FRED HAS BEEN PARTIALLY PUSHED OUT OF THE MICROCATHETER. PROXIMAL TO BUT NOT AT THE END, THERE IS COMPACTION OF THE FRED, SUGGESTING IT HAS BEEN OVERLOADED. AT THE END, THERE IS PROTRUSION OF THE BRAIDED PART OF THE FRED BEYOND WHERE IT SHOULD NORMALLY END, AND THAT PART IS SEVERELY FISH MOUTHED TO THE LEVEL OF THE DISTAL MARKERS OF THE OUTER STENT. IT IS THE MEDICAL OPINION THAT THIS IS LIKELY WHAT CAUSED THE THROMBOSIS OF THE DISTAL END OF THE FRED AND LED TO ITS REMOVAL. LOT STATEMENT A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE. IFU STATEMENT: THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBUS AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION, WHEN CONFIRMATORY ANGIOGRAPHY WAS PERFORMED, THE DISTAL SIDE OF THE STENT WAS NOT CONTRASTED. THE STENT WAS THEREFORE WITHDRAWN ALONG WITH A MICROCATHETER AND WERE REMOVED FROM THE PATIENT. THE PHYSICIAN LATER GAVE UP ON FLOW DIVERTER IMPLANTATION AND EMBOLIZED THE ANEURYSM WITH COILS. SUBSEQUENTLY, THE ANEURYSM EMBOLIZATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HEALTH DAMAGE. ANEURYSM LOCATION: ICA, C2. THERE WAS NO SIDE BRANCH VESSEL COVERED. THE ANEURYSM SIZE: 3.9 MM IN NECK LENGTH, 5.6 MM IN WIDTH, 5.7 IN DEPTH, 6.5 MM IN HEIGHT. IT WAS AN UNRUPTURED, SACCULAR LEFT SIDE LESION. PARENT VESSEL DIAMETER: 3.8 MM ON THE PROXIMAL SIDE AND 4.2 MM ON THE DISTAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508494 FRED 27 FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED®) SYSTEM OUT MICROVENTION INC. MV-F451827 0000115753 04987892121906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PREOP ASA PRASUGREL HEADWAY17 SOFIA