BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED X27

    MDR report key: 12917562 · Received December 2, 2021

    Report

    Report Number
    2032493-2021-00476
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 2, 2021
    Report Date
    June 10, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429107454
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETED IMAGE REVIEW CONTAINED WITHIN ZIP FOR COMPLIANT (B)(4). IMAGE REVIEW PERFORMED BY MVI, INC., MD. IMAGE REVIEW ASSESSMENT: IMAGING REVIEWED: REVIEWED THE 9GB DICOM FILE THAT YOU SENT. IT INCLUDES: ANGIO + XPER CT IMAGES OF THE EMBOLIZATION PROCEDURE - (B)(6) 2021. MRI/MRA - (B)(6) 2021. MRI/MRA - (B)(6) 2021. ANGIO + XPER CT, MRI/MRA IMAGES, (B)(6) 2022. ANGIO + XPER CT IMAGES, (B)(6) 2022. ANGIO + XPER CT IMAGES, (B)(6) 2022. MRI/MRA, (B)(6) 2023. THESE DO NOT ADD TO MY PRIOR REPORT AND ARE CONSISTENT WITH YOUR OWN DETAILED REPORT. ON (B)(6) 2022, THE LEFT OPHTHALMIC ANEURYSM STILL FILLS AND THE OPHTHALMIC ARTERY, WHICH AROSE FROM THE BASE OF THE ANEURYSM, ALSO FILLS ANTEGRADE. THE PREVIOUSLY SEEN LEFT SHA/CAROTID CAVE ANEURYSM IS OCCLUDED. THERE IS MINIMAL, LESS THAN 50% IN-STENT STENOSIS. ON (B)(6) 2022, BOTH LEFT SIDED ANEURYSM ARE GONE AND THERE IS ALMOST NO REMAINING IN-STENT STENOSIS. THE PATIENT HAS AN INCIDENTAL SMALL LEFT CONVEXITY MENINGIOMA THAT IS STABLE THROUGH TIME. A SET OF FIVE IMAGES WERE PROVIDED FOR REVIEW FOR THIS INVESTIGATION. IMAGES 1 AND 4 ARE A NON-SUBTRACTED LATERAL VIEW WITH NO CONTRAST AND A SUBTRACTED CONTRAST ROADMAP LATERAL VIEW DURING DEPLOYMENT. ABOUT 90% OF THE FRED IS DEPLOYED. THE PART THAT IS OPEN APPEARS NORMAL. THE PART THAT IS STILL INSIDE THE MICROCATHETER SHOWS THAT ONE OF THE FOUR RADIOPAQUE MARKERS OF THE PROXIMAL FLARED ENDS IS POSITIONED ABNORMALLY, AS SUCH AS IT IS ALIGNED WITH THE PROXIMAL PART OF THE BRAIDED PORTION OF THE STENT. IMAGES 2 AND 3 ARE NON-SUBTRACTED LATERAL PROJECTIONS AFTER TOTAL DEPLOYMENT/RELEASE OF THE FRED AND AGAIN SHOW 3 NORMAL DISTAL MARKERS, BUT ONE THAT IS ALIGNED WITH THE PROXIMAL PART OF THE BRAID. IMAGE 5 IS A FLAT PLATE CT OF THE FRED, IN LATERAL PROJECTION, SHOWING THE SAME ABNORMALITY OF THAT ONE PROXIMAL FLARED END RADIOPAQUE MARKER. THE REASON FOR THIS MARKER ABNORMALITY IS NOT EVIDENT IN THE IMAGES. HOWEVER, ONE CAN SAY THAT THE PROBLEM WAS ALREADY PRESENT WHEN THE DEVICE WAS INSIDE THE MICROCATHETER, BEFORE FULL DEPLOYMENT. THE PHYSICAL DEVICE WAS NOT RETURNED FOR ANALYSIS; WITHOUT THE RETURN AND THE PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION COULD NOT DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    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 IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS, AND PROCEDURE IMAGES NOT PROVIDE. THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED.. IF ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED BASED ON ADDITIONAL INFORMATION RECEIVED, IMAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A (B)(6) STUDY THAT DURING TREATMENT OF AN ACI ANEURYSM WITH A FRED X FLOW DIVERTER STENT, THE FLARED ENDS DID NOT APPEAR IN THE CORRECT ALIGNMENT AFTER DEPLOYMENT. ONE OF THE FLARED ENDS WAS ROLLED OUTWARDS. AN ATTEMPT WAS MADE TO MODEL THE FLARED END TO THE VESSEL WALL. A CONTROL ANGIOGRAPHY AFTER ONE DAY REVEALED THE STENT TO LOOKED FINE. REPORTEDLY, THE PATIENT EXPERIENCED DYSARTHRIA, RIGHT SIDE WEAKNESS AND DELAYED INFARCT. CLINICAL IMPACT DESCRIBED AS PATIENT HAD A PERMANENT DEFICIT. THE PATIENT NEUROLOGICAL EVALUATION AT DISCHARGE WAS MRS SCORE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814140 FRED X27 INTRALUMINAL DEVICES OUT MICROVENTION, INC. XFRED3516-MVE 21011911A 00842429107454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability| R