BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED JR.

    MDR report key: 15674711 · Received October 26, 2022

    Report

    Report Number
    0002032493-2022-00501
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    October 14, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MICROVENTION, INC
    Product Code
    OUT
    UDI-DI
    00812636020747
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED 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 TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE INCIDENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBUS AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THIS FOLLOW UP REPORT IS ALSO BEING SUBMITTED TO INCLUDE CORRECTION FROM FEI BASED TO CFN BASED. FEI WAS SELECTED IN ERROR ON OUR INITIAL REPORT. H10 A SEARCH FOR NON CONFORMANCES ASSOCIATED WITH THE REPORTED PART AND LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE INVESTIGATION OF THE RETURNED STENT SYSTEM FOUND THE STENT RETURNED FULLY DEPLOYED WITH SLIGHT FRAYING OF THE DISTAL INNER STENT. FUNCTIONAL TESTING WAS PERFORMED AND FOUND THE STENT WAS ABLE TO SUCCESSFULLY ADVANCE THROUGH AN INHOUSE MICROCATHETER AND FULLY OPEN UPON DEPLOYMENT. THE FRAYING AT THE DISTAL END OF THE INNER STENT IN TANDEM WITH THE TORTUOUS ANATOMY MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT HOWEVER REPLICATION TESTING OF THE RETURNED DEVICE WITH THE EXACT ANATOMICAL ENVIRONMENT OF THE PROCEDURE COULD NOT BE PERFORMED DURING THE INVESTIGATION. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT EVALUATED AS A PART OF THIS EVALUATION SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE FRAYING INNER STENT BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. WITHOUT IMAGING THE INVESTIGATION IS UNABLE TO VERIFY THE PRESENCE OF A THROMBUS AS DESCRIBED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANTATION OF THE FRED JR., A THROMBUS FORMED DISTALLY, WHEREUPON THE FRED JR. WAS WITHDRAWN, AND IT WAS FOUND THE FRED JR. HAD NOT OPENED. A DIFFERENT EMBOLIZATION DEVICE WAS THEN IMPLANTED. PATIENT HAS A HISTORY OF LEFT MEDIA ANEURYSM THAT WAS TREATED 2.5 YEARS PRIOR WITH CLIPPING AND SUBSEQUENT COILING. THE PATIENT 'S CONDITION REPORTED TO BE GOOD AND STABLE.

    Description of Event or Problem · 0

    DURING IMPLANTATION OF THE FRED JR. A THROMBUS FORMED DISTALLY WHEREUPON THE FRED JR. WAS WITHDRAWN. THE FRED JR. HAD NOT OPENED. A PIPELINE 3X16 WAS THEN IMPLANTED. PATIENT HAS A HISTORY OF LEFT MEDIA ANEURYSM THAT WAS TREATED 2.5 YEARS PRIOR WITH CLIPPING AND SUBSEQUENT COILING. THE PATIENTS CONDITION REPORTED TO BE GOOD AND STABLE. ADDITIONAL CLARIFICATION RECEIVED NOTES THE CLIPPING TOOK PLACE 2.5 YEARS AGO AND THE ORIGINAL COILING JUST A YEAR AGO AS THERE WAS INFLOW INTO THE ANEURYSM. THE RECENT PLAN WAS TO IMPLANT A FLOW DIVERTER INTO THE CARRIER VESSEL IN FRONT OF THE ANEURYSM. IT IS NOTED THE ANATOMY WAS TORTUROUS. THE FRED JR. WAS IMPLANTED BUT NOT YET DETACHED WHEN A THROMBUS WAS SEEN DISTAL TO THE FRED JR. THE FRED JR. STENT DID NOT OPEN AT ALL BEFORE IT WAS WITHDRAWN. NO MEDICAL OR SURGICAL INTERVENTION OR TREATMENT WAS NEEDED FOR THE THROMBUS. ALTHOUGH REQUESTED NO IMAGES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509404 FRED JR. FLOW DIVERTER OUT MICROVENTION, INC FREDJR3014 21071255Z 00812636020747

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other