BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 23639822 · Received November 24, 2025

    Report

    Report Number
    2029214-2025-02488
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 24, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZHOU, H. W., FOULSHAM, W., & ROSSIN, E. J. CENTRAL RETINAL ARTERY OCCLUSION FOLLOWING SPHENOPALATINE ARTERY EMBOLIZATION: A CASE REPORT AND REVIEW OF THE LITERATURE. RETINAL CASES AND BRIEF REPORTS 2024. DOI: 10.1097/ICB.0000000000001689 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF VISION LOSS, RETINAL ARTERY OCCLUSION, MILD BILATERAL NUCLEAR SCLEROSIS, EDEMA, LOSS OF DISTINCTION OF INNER RETINAL LAYERS, DENSE RELATIVE AFFERENT PUPILLARY DEFECT IN ASSOCIATION WITH CONCERTO COIL EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO REPORT OF A CASE OF CENTRAL RETINAL ARTERY OCCLUSION FOLLOWING SPHENOPALATINE ARTERY (SPA) EMBOLIZATION. THE AUTHORS REVIEWED 1 CASE OF A PATIENT TREATED FOR SPHENOPALATINE ARTERY BLEED USING CONCERTO COIL EMBOLIZATION. THE PATIENT WAS A 68-YEAR-OLD FEMALE. THE LIKELY MECHANISM OF INJURY IN THIS CASE WAS THE PASSAGE OF EMBOLIC MATERIAL THROUGH EXTERNAL CAROTID ARTERY- INTERNAL CAROTID ARTERY (ECA-ICA) ANASTOMOSES. THE PATIENT HAD SEVERE STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY INCREASING PROBABILITY OF COLLATERAL VASCULATURE FROM THE ECA SUPPLY TO BRANCHES OF THE ICA THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE CONCERTO COIL. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: PAINLESS RIGHT SIDED VISION LOSS DENSE RELATIVE AFFERENT PUPILLARY DEFECT NOTED IN THE RIGHT EYE LOSS OF DISTINCTION OF THE INNER RETINAL LAYERS EDEMA IN RIGHT EYE MILD BILATERAL NUCLEAR SCLEROSIS FUNDUS EXAM OF THE RIGHT EYE REVEALED A CHERRY-RED SPOT IN THE MACULA (EVIDENCE OF RETINAL THICKENING) AND WIDESPREAD VASCULAR ATTENUATION. 3 DAYS LATER CONFIRMED SEVERE DELAYED PERFUSION AND PERIPHERAL NON-PERFUSION OF THE RIGHT EYE WITH NORMAL PERFUSION OF THE LEFT WHICH WAS DIAGNOSED AS OCCLUSION OF THE CENTRAL RETINAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475096 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other| L