BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5929819 · Received September 6, 2016

    Report

    Report Number
    2029214-2016-00781
    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 HEALTH CARE PROFESSIONAL

    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 2 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, (B)(6) NEUROSURGERY, JTN.

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDRS 2029214-2016-00779 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 SECOND SUBJECT WAS A (B)(6) MALE THAT PRESENTED WITH TRIGEMINAL NEURALGIA. TREATMENT OF THE DURAL ARTERIOVENOUS FISTULA (DAVF) LOCATED IN THE MECKEL CAVE 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
    581677 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention