BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20356529 · Received October 2, 2024

    Report

    Report Number
    2029214-2024-01754
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    March 26, 2009
    Report Date
    October 2, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR LITERATURE ARTICLE. 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

    MACDONALD, MILLAR, BARKER; INTERVENTIONAL NEURORADIOLOGY; 2010; 52:387¿395; ENDOVASCULAR TREATMENT OF CRANIAL DURAL ARTERIOVENOUS FI STULAE: A SINGLE-CENTRE, 14-YEAR EXPERIENCE AND THE IMPACT OF ONYX ON LOCAL PRACTISE; DOI 10.1007/S00234-009-0620-X. LITERATURE WAS REVIEWED REGARDING: "ENDOVASCULAR TREATMENT OF CRANIAL DURAL ARTERIOVENOUS FISTULAE: A SINGLE-CENTRE, 14-YEAR EXPERIENCE AND THE IM PACT OF ONYX ON LOCAL PRACTISE". THE TIME FRAME OF THIS STUDY WAS: BETWEEN 1994 AND 2008. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX EMBOLIZATION, REBAR-14 OR 10 MICROCATHETER. DEATHS OCCURRED IN THE STUDY POPULATION: THE PROVIDED CONTEXT DOES NOT MENTION ANY DEATHS OCCURRING IN THE STUDY POPULATION. PRIMARY ENDOVASCULAR TREATMENT WAS PERFORMED OR ATTEMPTED IN 52 FISTULAE. ENDOVASCULAR CURE WAS ACHIEVED IN 30 (57.7%). THIS PERCENTAGE RISES TO 66.7% IF THE SEVEN CASES OF FAILURE TO ACCESS THE FISTULA ARE EXCLUDED. SUCCESSFUL OCCLUSION WAS SUBSEQUENTLY ACHIEVED BY SURGICAL LIGATION IN 18 CASES (34.6%), AND A FURTHER CASE REQUIRED SUPPLEMENTARY, POST-OPERATIVE EMBOLISATION TO ACHIEVE OCCLUSION, GIVING A TOTAL CURE RATE OF 94.2%. TWO OF THE FOUR CAVERNOUS DURAL FISTULAE REMAINED PATENT FOLLOWING ATTEMPTED TREATMENT DUE TO FAILED ACCESS WHICH, TOGETHER WITH THE SINGLE PERSISTENT TYPE III FISTULA, GIVES AN OVERALL RATE OF FAILED TREATMENT OF 5.8% AMONG PATIENT ADVERSE EVENTS INCLUDED:  1. THREE PATIENTS HAD TRANSIENT WORSENING OF THEIR PRESENTING SYMPTOMS IMMEDIATELY FOLLOWING EMBOLISATION: TRANSIENT WORSENING OF PROPTOSIS AND TRIGEMINAL PAIN. TRANSIENT WORSENING OF EYE SIGNS. TRANSIENT WORSENING OF HEMIPARESIS AND DROWSINESS. 2. ONE PATIENT HAD NEW TRANSIENT SYMPTOMS WITH VISUAL DISTURBANCES AND RED EYES 7 DAYS AFTER TRANSVENOUS EMBOLISATION. 3. ONE PATIENT HAD AN ASYMPTOMATIC FEMORAL ARTERIOVENOUS FISTULA WHICH WAS TREATED SURGICALLY WITHOUT INCIDENT. 4. ONE PATIENT HAD A MIDDLE CEREBRAL ARTERY TERRITORY INFARCT DURING FOLLOW-UP ANGIOGRAPHY AFTER FAILED EMBOLISATION AND SUBSEQUENT SURGICAL TREATMENT. 5. TRANSIENT POST-EMBOLISATION SYMPTOMS RECORDED WERE HEADACHE OR VERTIGO NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137546 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention