BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRED X27

    MDR report key: 15008709 · Received July 13, 2022

    Report

    Report Number
    2032493-2022-00279
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 23, 2022
    Report Date
    June 27, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429107454
    PMA / PMN Number
    P180027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 MANUFACTURING OF THE DEVICE. THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN AND EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE DEVICE IS RECEIVED, THE INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: H6: COMPONENT CODE: REMOVE 4755 AND ADD: 515, 3038, 3157. TYPE OF INVESTIGATION: REMOVE 4118, 4117; ADD: 10. INVESTIGATION FINDINGS: REMOVE 3233; ADD: 213. INVESTIGATION CONCLUSIONS: REMOVE 11; ADD: 67. THE INVESTIGATION OF THE STENT SYSTEM FOUND THE STENT RETURNED FULLY RETRIEVED INSIDE THE MICROCATHETER; FURTHERMORE, THE STENT WAS ABLE TO BE FULLY RETRIEVED INTO AN IN-HOUSE INTRODUCER DURING FUNCTIONAL TESTING AND THEREFORE, THIS COMPLAINT IS CONSIDERED UNCONFIRMED. THE STENT ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THROUGH THE RETURNED MICROCATHETER ON THE FIRST ATTEMPT BUT WAS ABLE TO ADVANCE SUCCESSFULLY ON A SECOND ATTEMPT. THE STENT WAS ABLE TO BE RETRIEVED INTO BOTH THE RETURNED MICROCATHETER AND AN IN-HOUSE MICROCATHETER. THE INVESTIGATION OF THE RETURNED DEVICE DID NOT FIND ANY DAMAGE OR OTHER ANOMALY THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF A PSEUDO-ANEURYSM IN THE V4 SEMENT OF THE LEFT ARTERIA VERTIBRALIS, THE FLOW DIVERTER WAS UNABLE TO BE RE-SHEATHED COMPLETELY DURING RE-POSITIONING. THE DEVICE WAS NOT ABLE TO BE RETRIEVED COMPLETELY; ONE-THIRD OF THE DEPLOYED PORTION OF THE STENT WAS ABLE TO BE RETRIEVED. THUS, THE STENT WAS REMOVED ALONG WITH THE MICROCATHETER "AS ONE" WITHOUT FURTHER ISSUES. THE FLOW DIVERTER WAS THE ONLY DEVICE USED WITH THE MICROCATHETER. THERE WAS NO VISIBLE DAMAGE TO THE MICROCATHETER. THERE WAS NO PATIENT INJURY. THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451625 FRED X27 FLOW DIVERTER OUT MICROVENTION, INC. XFRED3516-MVE 20102313QM 00842429107454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEADWAY 27