BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 12816295 · Received November 15, 2021

    Report

    Report Number
    2029214-2021-01474
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    April 10, 2020
    Report Date
    November 15, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WINKLER, E. A., LU, A., MORSHED, R. A., YUE, J. K., RUTLEDGE, W. C., BURKHARDT, J.-K., PATEL, A. B., AMMANUEL, S. G., BRAUNSTEIN, S., FOX, C. K., FULLERTON, H. J., KIM, H., COOKE, D., HETTS, S. W., LAWTON, M. T., ABLA, A. A., <(>&<)>AMP; GUPTA, N. (2020). BRINGING HIGH-GRADE ARTERIOVENOUS MALFORMATIONS UNDER CONTROL: CLINICAL OUTCOMES FOLLOWING MULTIMODALITY TREATMENT IN CHILDREN. JOURNAL OF NEUROSURGERY: PEDIATRICS, 26(1), 82¿91. HTTPS://DOI.ORG/10.3171/2020.1.PEDS19487 AGE OR DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    WINKLER, E. A., LU, A., MORSHED, R. A., YUE, J. K., RUTLEDGE, W. C., BURKHARDT, J.-K., PATEL, A. B., AMMANUEL, S. G., BRAUNSTEIN, S., FOX, C. K., FULLERTON, H. J., KIM, H., COOKE, D., HETTS, S. W., LAWTON, M. T., ABLA, A. A., <(>&<)>AMP; GUPTA, N. (2020). BRINGING HIGH-GRADE ARTERIOVENOUS MALFORMATIONS UNDER CONTROL: CLINICAL OUTCOMES FOLLOWING MULTIMODALITY TREATMENT IN CHILDREN. JOURNAL OF NEUROSURGERY: PEDIATRICS, 26(1), 82¿91. HTTPS://DOI.ORG/10.3171/2020.1.PEDS19487 SUMMARY: BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS) ARE DYSPLASTIC, FRAGILE CLUSTERS OF BLOOD VESSELS FORMED BY ABNORMAL CONNECTIONS BETWEEN ARTERIES AND VEINS LEADING TO VASCULAR SHUNTING, WHICH CAN CAUSE SPONTANEOUS INTRACEREBRAL HEMORRHAGES. AVMS ARE THE LEADING CAUSE OF NONTRAUMATIC INTRACEREBRAL HEMORRHAGE IN CHILDREN AND ACCOUNT FOR 30%¿50% OF ALL SPONTANEOUS HEMORRHAGES.1¿3 BRAIN HEMORRHAGE IS ASSOCIATED WITH A MORTALITY RATE OF 25%,4 AND RECENT STUDIES IN CHILDREN HAVE ESTIMATED THE ANNUAL HEMORRHAGE RATE TO RANGE BETWEEN 0.9% AND 6.3%.1,3 WHEN DIAGNOSED IN CHILDHOOD OR ADOLESCENCE, THE ANNUALIZED HEMORRHAGE RISK OVER A GREATER NUMBER OF EXPECTED YEARS TO LIVE IN COMPARISON WITH ADULTS LEADS TO A HIGH CUMULATIVE LIFETIME HEMORRHAGE RISK. INTERVENTION TO ACHIEVE AVM OBLITERATION IS THEREFORE OFTEN FAVORED TO MITIGATE THE POTENTIAL MORBIDITY OF FUTURE HEMORRHAGE. IDENTIFIED EVENTS: 1. IN RUPTURED AVMS, 31 PATIENTS DID NOT HAVE COMPLETE OBLITERATION ACROSS TREATMENT MODALITIES. 18 PATIENTS REQUIRED EMERGENCY DECOMPRESSIVE HEMICRANIECTOMY. NO RE-HEMORRHAGE EVENTS WERE REPORTED FOLLOWING SURGICAL DECOMPRESSION PRIOR TO MORE DEFINITIVE THERAPY. 2. IN RUPTURED AVMS, 15 PATIENTS HAD PREOPERATIVE EMBOLIZATION PERFORMED. 13 PATIENTS REQUIRED A SECOND SURGICAL PROCEDURE OR RADIOS URGICAL TREATMENT AFTER THE INITIAL RESECTION, RESPECTIVELY, FOR RESIDUAL SHUNTING ON POSTOPERATIVE DSA. 3. IN UNRUPTURED AVMS, 30 PATIENTS DID NOT HAVE COMPLETE OBLITERATION ACROSS TREATMENT MODALITIES. 4. IN UNRUPTURED AVMS, 12 PATIENTS HAD PREOPERATIVE EMBOLIZATION PERFORMED. 4 PATIENTS REQUIRED REPEAT SURGERY FOR RESIDUAL SHUNTING. 5. 2 PATIENTS HAD POSTTREATMENT HEMORRHAGE AS A RESULT OF 1 RESIDUAL AVM AND 1 RECURRENCE FOLLOWING RESECTION. 6. 11 PATIENTS (9.8%) OF PATIENTS UNDERGOING RUPTURED AVMS TREATMENT HAD PROCEDURAL COMPLICATIONS AND NEW TRANSIENT OR PERSISTENT NEUROLOGICAL DEFECTS OCCUR. 7. 5 PATIENTS (7.6%) OF PATIENTS UNDERGOING UNRUPTURED AVMS TREATMENT HAD PROCEDURAL COMPLICATIONS AND NEW TRANSIENT OR PERSISTENT N EUROLOGICAL DEFECTS OCCUR. 8. 1 PATIENT WITH AN UNRUPTURED SM GRADE IV CEREBELLAR AVM HAD AN ARTERIAL INFARCTION OCCUR WHILE UNDERGOING RESECTION WITH PREOPERATIVE EMBOLIZATION. AFTER THROMBOSIS OF THE VENOUS OUTFLOW AND ONSET OF CLINICAL SYMPTOMS, THIS RESULTED IN SEVERE BRAINSTEM EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707798 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention