BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6517675 · Received April 25, 2017

    Report

    Report Number
    2029214-2017-00537
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS WERE MADE TO GATHER SPECIFIC DETAIL, HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO ALLEGATION THAT A MALFUNCTION OR DEFICIENCY OF THE EMBOLIC MATERIAL OCCURRED DURING THE PROCEDURE. NEUROLOGICAL CHANGES AND HEMORRHAGES ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). THERE IS NO EVIDENCE SUGGESTING THAT THE MATERIAL WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENT. LINKED EVENTS: 2029214-2017-00537 2029214-2017-00538 2029214-2017-00539 2029214-2017-00540 2029214-2017-00541.

    Description of Event or Problem · 1

    CITATION: ONYX OR COMBINED WITH OTHER EMBOLIC MATERIALS IN THE TREATMENT OF INTRACRANIAL ARTERIOVENOUS MALFORMATIONS CHEN GUANG-ZHONG' , SHU HANG, LIU MAO-CAI, ZENG SHAO-JIAN, ZHAN SHENG-QUAN, ZHOU DONG, UN XIAO-JENG, TANG KAI, ZHOU DE-XIANG, LI ZHA O-JIE, U TIE-ZIN. MEDTRONIC RECEIVE THE FOLLOWING REPORTS: 183 PATIENTS WERE TREATED. 2 CASES OF POSTOPERATIVE BLEEDING, 1 CASE HAD NO OBVIOUS IMPROVEMENT. 143 PATIENTS WERE FOLLOWED UP FOR 1 TO 18 MONTHS, AMONG THEM 3 HAD RE-BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302575 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other