BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5929763 · Received September 6, 2016

    Report

    Report Number
    2029214-2016-00780
    Event Type
    Injury
    Date Received
    September 6, 2016
    Report Date
    August 10, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX MODEL AND LOT NUMBER WERE NOT PROVIDED. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER NO RESPONSE HAS BEEN RECEIVED. THE ONYX WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. MDR 1 OF 3 FROM THE LITERATURE REVIEW OF INCOMPLETE ONYX EMBOLIZATION RESULTING IN GAMMA KNIFE TREATMENT. CITATION: J LIU, X LI, ET AL. TRANSARTERIAL ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS IN ADULTS 21.MARCH.2016, TURKISH NEUROSURGERY, JTN.

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDRS 2029214-2016-00781 AND 2029214-2016-00782 FOR THE OTHER 2 MDRS ASSOCIATED WITH THIS LITERATURE REVIEW.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE REVIEW THAT 3 PATIENTS REQUIRED GAMMA KNIFE RADIOSURGERY DUE TO INCOMPLETE EMBOLIZATION WITH THE ONYX. THE FIRST SUBJECT , WAS A (B)(6) FEMALE THAT PRESENTED WITH CHEMOSIS, BRUITS, AND BLURRED VISION. TREATMENT OF THE DURAL ARTER IOVENOUS FISTULA (DAVF) LOCATED IN THE RIGHT CAVERNOUS SINOUS (CS) WITH THE ONYX EMBOLIZATION WAS INCOMPLETE, AS INDICATED IN THE POST-TREATMENT ANGIOGRAM, WHICH SHOWED EVIDENCE OF REMNANT FISTULA. AS A RESULT, THE PATIENT UNDERWENT GAMMA KNIFE RADIOSURGERY. FOLLOW UP GLASGOW OUTCOME SCALE (GOS) OF THE PATIENT IS 5 (RESUMPTION OF NORMAL LIFE DESPITE MINOR DEFICITS). CITATION: J LIU, X LI, ET AL. TRANSARTERIAL ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS IN ADULTS 21.MARCH.2016, JOURNAL OF (B)(6) NEUROSURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581788 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention