BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 12709969 · Received October 28, 2021

    Report

    Report Number
    2029214-2021-01347
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    December 8, 2020
    Report Date
    October 28, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SEE MANUFACTURER REPORT # 2029214-2021-01346 FOR OTHER ADVERSE EVENTS MENTIONED IN THE ARTICLE. GARCÍA-DUQUE S, GARCÍA-LEAL R, IZA-VALLEJO B, ET AL. BRAIN ARTERIOVENOUS MALFORMATIONS: IMPACT OF NEUROLOGIC STATUS, BLEEDING, AND TYPE OF TREATMENT ON FINAL OUTCOME. JOURNAL OF NEUROLOGICAL SURGERY PART A, CENTRAL EUROPEAN NEUROSURGERY. 2021;82(2):130-137. DOI:10.1055/S-0040-1714659. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    GARCÍA-DUQUE S, GARCÍA-LEAL R, IZA-VALLEJO B, ET AL. BRAIN ARTERIOVENOUS MALFORMATIONS: IMPACT OF NEUROLOGIC STATUS, BLEEDING, AND TYPE OF TREATMENT ON FINAL OUTCOME. JOURNAL OF NEUROLOGICAL SURGERY PART A, CENTRAL EUROPEAN NEUROSURGERY. 2021;82(2):130-137. DOI:10 .1055/S-0040-1714659 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO PERFORM A RETROSPECTIVE STUDY OF ARTERIOVENOUS MALFORMATION (AVM) PATIENTS. THERE WERE 117 PATIENTS INCLUDED IN THE REVIEW (59 FEMALE, AVERAGE AGE 41.3 YEARS). ONYX WAS USED FOR EMBOLIZATION PROCEDURES AFTER 2002, EITHER AS EMBOLIZATION ONLY OR PREOPERATIVELY BEFORE SURGERY. TREATMENT DISTRIBUTION IN THE SPETZLER¿MARTIN GRADES I¿III WAS AS FOLLOWS: 52 (54.6%) SURGERY, 31 (32.35%) RADIOSURGERY, 2 (0.02%) EMBOLIZATION, AND 11 (12%) CONSERVATIVE FOLLOW-UP. TREATMENT DISTRIBUTION IN SPETZLER¿MARTIN GRADES IV AND V WAS AS FOLLOWS: 4 (20%) SURGERY, 7 (35%) RADIOSURGERY, AND 10 (45%) CONSERVATIVE FOLLOW-UP. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: - FORTY-SIX PATIENTS EXPERIENCED A COMPLICATION. THE MOST FREQUENT COMPLICATIONS WERE HYDROCEPHALUS AND FOCAL DEFICIT AT 9 EACH, MENINGITIS AT 6, AND PNEUMONIA AT 6. - SIX PATIENTS EXPERIENCED HEMORRHAGE AFTER DIAGNOSIS, ONE BETWEEN THE ENDOVASCULAR AND SURGICAL THERAPY, ONE AFTER INCOMPLETE SURGERY, AND THE REMAINING AFTER RADIOSURGERY, WHILE THE NIDUS STILL WAS PATENT. THE OUTCOME OF THIS GROUP WAS POOR, WITH ONLY ONE PATIENT TREATED WITH RADIOSURGERY SURVIVING AFTER THE HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610336 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other