BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6517139 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00503
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    October 28, 2010
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FENG XU, WEI NI, YUJUN LIAO, YUXIANG GU, BIN XU, BING LENG, DONGLEI SONG. ONYX EMBOLIZATION FOR THE TREATMENT OF BRAIN A RTERIOVENOUS MALFORMATIONS. ACTA NEUROCHIR (2011). PUBLISHED ONLINE: 28 OCTOBER 2010 THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EXPERIENCE IN THE TREATMENT OF BRAIN AVMS WITH ONYX EMBOLIZATION. BETWEEN JANUARY 2004 AND DECEMBER 2007, 86 PATIENTS WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THE AUTHORS CONCLUDE THAT ALTHOUGH ONYX ALLOWS MODERATE OBLITERATION RATES, COMBINED MANAGEMENT, SUCH AS ADJUNCTIVE EMBOLIZATION WITH MICROSURGERY OR RADIOSURGERY, MAY BE EFFECTIVE FOR SELECTED LARGE AVMS. THE MEAN PATIENT AGE WAS 30.3 YEARS (RANGE, 8¿55 YEARS). THERE WERE 51 MEN AND 35 WOMEN. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THIS WAS AN EVENT CAPTURED THROUGH LITERATURE REVIEW. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THIS WAS AN EVENT CAPTURED THROUGH LITERATURE REVIEW. THERE IS LIMITED PATIENT AND DEVICE INFORMATION AVAILABLE, HOWEVER, IN THIS CASE, THE HEMORRHAGES WERE REPORTED POST PROCEDURE. WITHIN THE ARTICLE, THERE WAS NO CONFIRMED DEFECT OR DEVICE DEFICIENCY. HEMORRHAGIC COMPLICATIONS FROM HEMODYNAMIC CHANGES INDUCED BY EMBOLIZATION ARE KNOWN INHERENT RISKS OF THE EMBOLIZATION PROCEDURE AND ARE DOCUMENTED IN THE ONYX INSTRUCTIONS FOR USE (IFU). BASED ON THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON EACH CASE; SHOULD THE INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00499, 2029214-2017-00500, 2029214-2017-00501, 2029214-2017-00502, AND 2029214-2017-00503.

    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 THROUGH LITERATURE REVIEW THAT 3 PATIENTS EXPERIENCED HEMORRHAGES AFTER THE EMBOLIZATION PROCEDURE. ONE PATIENT HAD AN INTRAVENTRICULAR HEMORRHAGE AND 2 EXPERIENCED SUBARACHNOID HEMORRHAGES. THE PATIENTS PRESENTED WITH NON-NEUROLOGIC DEFICITS. THE PATIENTS WERE UNDERGOING ONYX EMBOLIZATION TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298620 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other