BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 6074001 · Received November 2, 2016

    Report

    Report Number
    2029214-2016-00967
    Event Type
    Death
    Date Received
    November 2, 2016
    Report Date
    October 5, 2016
    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

    PLEASE REFERENCE MDR NUMBERS: 2029214-2016-00964, 2029214-2016-00965, AND 2029214-2016-00968 FOR THE OTHER MDRS SUBMITTED FROM THIS LITERATURE REVIEW.

    Additional Manufacturer Narrative · 1

    CITATION: C. LI · X. YANG · Y. LI · C. JIANG · Z. WU. ENDOVASCULAR TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS PRESENTING WITH INTRACRANIAL HEMORRHAGE IN 46 CONSECUTIVE PATIENTS: WITH EMPHASIS ON TRANSARTERIAL EMBOLIZATION WITH ONYX. CLIN NEURORADIOL (2016) 26:301¿308 DOI 10.1007/S00062-014-0362-Y. PUBLISHED ONLINE: 13 DECEMBER 2014 THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, INCLUDING ANY PROCEDURAL DETAILS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE ONYX IFU ADVISES: "STOP INJECTION IF INCREASED RESISTANCE TO THE ONYX¿ LES INJECTION IS OBSERVED. IF INCREASED RESISTANCE OCCURS, DETERMINE THE CAUSE (E.G., ONYX¿ LES OCCLUSION IN CATHETER LUMEN) AND REPLACE THE CATHETER. DO NOT ATTEMPT TO CLEAR OR OVERCOME RESISTANCE BY APPLYING INCREASED INJECTION PRESSURE, AS USE OF EXCESSIVE PRESSURE MAY RESULT IN CATHETER RUPTURE AND EMBOLIZATION OF UNINTENDED AREAS."

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT ONE PATIENT ENCOUNTERED MIGRATION OF THE ONYX EMBOLUS INTO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) AND DIED OF MULTIPLE ORGAN FAILURE 10 DAYS AFTER EVT. THIS WAS A RESULT OF COMPLICATIONS OF ONYX EMBOLUS INTO THE POSTERIOR INFERIOR CEREBELLAR ARTERY. THE PURPOSE OF THE STUDY DISCUSSED IN THE ARTICLE WAS TO EVALUATE THE EFFECTIVENESS AND SAFETY AS WELL AS THE CLINICAL AND ANGIOGRAPHIC RESULTS OF THE ENDOVASCULAR TREATMENT (EVT) FOR PATIENTS WITH HEMORRHAGIC DURAL ARTERIOBENOUS FISTULAS (DAVFS). FROM 2009 TO NOVEMBER 2014, 46 CONSECUTIVE PATIENTS WITH HEMORRHAGIC INTRACRANIAL DAVFS WERE ENROLLED. THE CLINICAL AND ANGIOGRAPHIC DATA WERE REVIEWED AND EVALUATED. IN THIS RETROSPECTIVE STUDY, ANGIOGRAPHIC AND CLINICAL OUTCOMES OF THE 46 PATIENTS WITH HEMORRHAGIC DAVFS TREATED WITH EVT WAS REVIEWED. THE AUTHORS CONCLUDED THAT EVT WAS EFFECTIVE AND SAFE IN THE MODERN MANAGEMENT OF RUPTURED INTRACRANIAL DAVFS, WITH COMPLETE CURE IN MOST LESIONS. CLINICAL OUTCOMES WERE GOOD DESPITE PATIENTS PRESENTING WITH INTRACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724205 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death