BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX LES

    MDR report key: 6517044 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00495
    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 ATERIOVENOUS 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. THERE IS LIMITED PATIENT AND DEVICE INFORMATION AVAILABLE, HOWEVER, IN THIS CASE, THE HEMORRHAGE OCCURRED BETWEEN 1-4 HOURS AFTER THE 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). ISCHEMIC OR HEMORRHAGIC COMPLICATIONS MAY RESULT IN VARIOUS FUNCTIONAL NEUROLOGICAL DEFICITS AND POSSIBLY DEATH, WHICH ARE ALSO DOCUMENTED IN THE 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 POST-INTERVENTIONALLY, THE PATIENT EXPERIENCED AN ACUTE INTRACRANIAL HEMORRHAGE BETWEEN 1 AND 4 HOURS AFTER THE EMBOLIZATION. IT WAS REPORTED THAT THE HEMORRHAGE WAS CAUSED BY PREMATURE OCCLUSION OF THE NIDAL DRAINING VEIN. AFTER BEING TREATED WITH EMERGENCY CRANIOTOMY AND REMOVAL OF THE HEMATOMA, THE PATIENT REVIVED WITH A PERMANENT DISABLING DEFICIT. THE PATIENT WAS RECEIVING ONYX EMBOLIZATION TO TREAT A BRAIN AVM (LOCATION UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297706 ONYX LES AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention