BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6071704 · Received November 1, 2016

    Report

    Report Number
    2029214-2016-00965
    Event Type
    Injury
    Date Received
    November 1, 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

    ADDITIONAL INFORMATION: PLEASE REFERENCE MDR NUMBERS: 2029214-2016-00967 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, THEREFORE THE CAUSE OF THE DIFFICULTIES COULD NOT BE DETERMINED. A TTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE ONYX IFU ADVISES, "DO NOT ALLOW MORE THAN 1 CM OF THE ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE ONYX¿ LES REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND POTENTIAL ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE. THE LONG-TERM EFFECTS OF AN ENTRAPPED CATHETER THAT IS LEFT IN A PATIENT ARE UNKNOWN, BUT POTENTIALLY COULD INCLUDE CLOT FORMATION, INFECTION, OR CATHETER MIGRATION." PLEASE REFERENCE MDR 2029214-2016-00964 FOR THE MICROCATHETER REFERENCED IN THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH A LITERATURE REVIEW THAT AN UNKNOWN MICROCATHETER BECAME ENTRAPPED DURING THE DURAL ARTERIOVENOUS FISTULA (DAVF) PROCEDURE, AND WAS STRETCHED AND BROKEN DURING RETRIEVAL. THERE WERE NO CLINICAL SYMPTOMS AS A RESULT. 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 INT RACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720687 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other