BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 6618733 · Received June 7, 2017

    Report

    Report Number
    2029214-2017-00741
    Event Type
    Injury
    Date Received
    June 7, 2017
    Report Date
    May 24, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX WAS NOT RETURNED AS IT WAS IMPLANTED IN THE PATIENTS; THEREFORE, PRODUCT ANALYSIS OF THE ONYX WAS NOT ABLE TO BE PERFORMED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS HAVE INTRACRANIAL HEMORRHAGES ARE KNOWN INHERENT RISKS OF THE ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN THE MATERIAL'S INSTRUCTIONS FOR USE. NO ISSUES WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE OR USE OF THE MATERIAL. THERE WAS NO REPORT OF ADDITIONAL MEDICAL INTERVENTION BEING REQUIRED. BASED ON THE REPORTED INFORMATION, THERE IS NO REASONABLY SUGGESTION THAT A MALFUNCTION OR QUALITY DEFICIENCY OF THE MATERIAL OCCURRING DURING THE TREATMENT PROCEDURE. THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENTS THAT WAS PROBABLY CAUSED BY HEMODYNAMIC CHANGES INDUCED BY THE PROCEDURE. THE PATIENT¿S CLINICAL STATUS DID IMPROVE SIGNIFICANTLY AND DID RETURN TO ACTIVE LIFE.

    Description of Event or Problem · 1

    CITATION: ¿USE OF ONYX (A PATENTED ETHYLENE-VINYL ALCOHOL COPOLYMER FORMULATION) EMBOLISATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS IN HONG KONG: INITIAL EXPERIENCE¿ GEORGE KC WONG. SIMON CH YU. XL ZHU. MICHAEL KM KAM. WS POON. MEDTRONIC RECEIVED REPORT THAT 9 PATIENTS WERE TREATED WITH ONYX 18. THE MEAN AGE OF THE PATIENTS WAS 30 YEARS, WITH A RANGE OF 18 TO 45 YEARS. ONE OF THESE PATIENTS WAS REPORTED TO HAVE DEVELOPED A CONVEXITY-RELATED SUBARACHNOID HEMORRHAGE EVIDENT ON POST-PROCEDURAL COMPUTED TOMOGRAPHY. THIS PATIENT WAS REPORTED TO HAVE RETURNED TO WORK/STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401263 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other