BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED X21

    MDR report key: 21340084 · Received February 7, 2025

    Report

    Report Number
    2032493-2025-00108
    Event Type
    Injury
    Date Received
    February 7, 2025
    Report Date
    February 7, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THE INFORMATION WAS NOT AVAILABLE. THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE, IMAGING OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. WEN, DAVID W., ET AL. "TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE FRED X FLOW DIVERTER STENT: MID-TERM ANGIOGRAPHIC AND SAFETY RESULTS." CLINICAL NEURORADIOLOGY (2025): 1-6.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE ARTICLE TITLED, "TREATMENT OF LNTRACRANIAL ANEURYSMS WITH THE FRED X FLOW DIVERTER STENT: MID-TERM ANGIOGRAPHIC AND SAFETY RESULTS", THERE WAS 1 REPORT OF INFARCT, 4 REPORTS OF INCOMPLETE OCCLUSION, 2 REPORTS OF RESIDUAL ANEURYSM, AND 2 REPORTS OF RESIDUAL NECK. THE STUDY WAS A RETROSPECTIVE REVIEW OF DATA INVOLVING CONSECUTIVE PATIENTS TREATED WITH THE FRED X DEVICE AT 2 CENTRES IN THE UNITED KINGDOM (UK), FROM MARCH 2021 TO DECEMBER 2022. POSTPROCEDURAL CLINICAL AND IMAGING ASSESSMENT OF THESE PATIENTS WAS CONDUCTED FROM MARCH 2021 TO MARCH 2024. THERE WAS A REPORT OF ONE LEFT CENTRUM SEMIOVALE INFARCT THAT WAS ASYMPTOMATIC THAT WAS DISCOVERED POST-PROCEDURE MRI. NO MORTALITY OCCURRED IN OUR SERIES OF PATIENTS. ALL THE PATIENTS INCLUDED IN THIS STUDY HAD AT LEAST 18 MONTHS OF CLINIC-RADIOLOGICAL FOLLOW UP, WITH THE MEAN DURATION OF FOLLOW-UP BEING 21.5 MONTHS (SD 3.1, RANGE 18-30 MONTHS). THE ANGIOGRAPHIC IMAGING MODALITIES USED DURING FOLLOWUP WAS MRI AND CT/CONE-BEAM CT IN 8.3%, MRI AND CATHETER ANGIOGRAM IN 16.7%, AND MRI ALONE IN 75%. AT THE LATEST AVAILABLE FOLLOW UP, COMPLETE OCCLUSION (RROC CLASS I) WAS ACHIEVED IN 83.3% OF TREATED ANEURYSMS. RESIDUAL NECK (RROC CLASS II) WAS SEEN IN 8.3% AND RESIDUAL ANEURYSM (RROC III) IN 8.3% OF ANEURYSMS RESPECTIVELY. THE 4 ANEURYSMS THAT WERE INCOMPLETELY OCCLUDED (RROC II OR III), DID SHOW REDUCTION IN SIZE ON POSTINTERVENTION FOLLOW UP IMAGING. HENCE DECISION WAS MADE TO CONTINUE IMAGING SURVEILLANCE AND RE-TREATMENT WAS NOT OFFERED. NO IN-STENT STENOSIS OR INTIMAL HYPERPLASIA WAS DETECTED ON FOLLOW-UP IMAGING IN ANY OF THE IMPLANTED FRED X FDS. HOWEVER THE MAJORITY OF CASES WERE FOLLOWED-UP USING MRI, WHICH IS LESS SENSITIVE TO IN-STENT STENOSIS/INTERNAL HYPERPLASIA COMPARED TO CATHETER ANGIOGRAM. THERE ARE SEVERAL LIMITATIONS IN THIS STUDY, INCLUDING THE RETROSPECTIVE DESIGN AND ANALYSIS OF FOLLOW-UP IMAGING WAS NOT CONDUCTED BY AN INDEPENDENT 3RD PARTY. THIS IMPLIES A CERTAIN DEGREE OF SELECTION AND REPORTING BIAS. ALSO, THE MOST COMMON IMAGING MODALITY USED DURING FOLLOW-UP WAS MRI, IN 75% OF CASES, RATHER THAN THE GOLD-STANDARD CATHETER ANGIOGRAM. THIS MAY RESULT IN UNDER-DETECTION OF IN-STENOSIS AND INTIMAL HYPERPLASIA. DUE TO THE SMALL COHORT SIZE, THE RATE OF ADVERSE EVENTS AND ANEURYSM OCCLUSION RATES MAY ALSO BE LESS ACCURATE COMPARED TO LARGER COHORT STUDIES, AND HENCE DIFFICULT TO DRAW DEFINITIVE CONCLUSIONS FROM. THE RESULTS OF OUR STUDY SUGGEST THAT THE SAFETY PROFILE OF THE FRED X FDS IS IN LINE WITH OTHER SIMILAR STUDIES AND MAY BE COMPARABLE TO THE ORIGINAL FRED DEVICE. THE RATES OF COMPLETE ANEURYSM OCCLUSION ALSO APPEAR TO BE COMPARABLE TO OTHER FDS WITH SURFACE MODIFICATION AND MAY BE SLIGHTLY HIGHER THAN THE ORIGINAL FRED. HOWEVER THERE ARE SEVERAL LIMITATIONS IN OUR STUDY, INCLUDING THE SMALL SAMPLE SIZE, WHICH PRECLUDES US FROM DRAWING DEFINITE CONCLUSIONS ON THE FRED X. FUTURE STUDIES WITH LARGER COHORTS AND LONGER TERM FOLLOW-UP WILL BE NECESSARY TO ASSESS THE LONG-TERM SAFETY PROFILE AND EFFICACY OF THE FRED X FDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638316 FRED X21 INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICROVENTION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other