BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX LES

    MDR report key: 6517129 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00502
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    October 28, 2010
    Report Date
    March 28, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    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. THERE IS LIMITED PATIENT, PROCEDURE AND DEVICE INFORMATION AVAILABLE; IN THIS ARTICLE THERE WAS NO INFORMATION PROVIDED ON THE AMOUNT OF ONYX REFLUX THAT OCCURRED, OR IF THERE WAS ANY CATHETER ENTRAPMENT THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE ONYX INSTRUCTIONS FOR USE (IFU) ADVISES, "DO NOT ALLOW MORE THAN 1 CM OF ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE ONYX REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE." HEMORRHAGE IS A KNOWN INHERENT RISK OF THIS PROCEDURE AND IS DOCUMENTED IN THE ONYX 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 EVENT: 2029214-2017-00501, 2029214-2017-00502 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, 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 A SEVERE INTRACEREBRAL HEMORRHAGE OCCURRED IN ONE PATIENT, WHICH WAS CAUSED BY OBVIOUS SHIFTING OF THE NIDUS DURING MICROCATHETER RETRIEVAL. THE PATIENT UNDERWENT A CRANTIOTOMY FOR HEMATOMA EVACUATION AND REMOVAL OF THE MALFORMATION, AND THE PATIENT WAS LEFT WITH DISABLING HEMIPARESIS. AT THE FOLLOW-UP, THE PATIENT¿S CONDITION WAS IMPROVED TO A NON-DISABLING RESIDUAL HEMIPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298607 ONYX LES AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention