BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6517634 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00533
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    May 31, 2005
    Report Date
    March 30, 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: DONGLEI SONG, BING LENG,YUXIANG GU, WEI ZHU, BIN XU, XIECHENG CHEN, LIANGFU ZHOU. CLINICAL ANALYSIS OF 50 CASES OF BAVM EMBOLIZATION WITH ONYX, A NOVEL LIQUID EMBOLIC AGENT. INTERVENTIONAL NEURORADIOLOGY 11: 179-184, 2005. THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EMBOLIZATION TECHNIQUE USING ONYX TO TREAT CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS), AS WELL AS THE EFFICACY. THE AUTHORS CONCLUDE THAT ONYX HAS A UNIQUE AND DISTINCTIVE SUPERIORITY IN TREATING CEREBRAL AVMS. BETWEEN SEPTEMBER 2003 AND MAY 2005, 50 PATIENTS WITH BAVMS WERE TREATED. THERE WERE 35 MEN AND 15 FEMALE PATIENTS WITH A MEAN AGE OF 28 YEARS (RANGE 12-47 YEARS). FUNCTIONAL NEUROLOGICAL DEFICITS SUCH AS VISUAL DEFICITS AND HEMIPLEGIA MAY BE RELATED TO HEMODYNAMIC CHANGES INDUCED BY THE EMBOLIZATION AND ARE KNOWN INHERENT RISKS OF THE EMBOLIZATION PROCEDURE WHICH ARE DOCUMENTED IN THE ONYX INSTRUCTION FOR USE. THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICES WERE DEFECTIVE. BASED ON THE REPORTED INFORMATION PER THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENTS IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THE ARTICLE. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00529, 2029214-2017-00530, 2029214-2017-00531, 2029214-2017-00532, 2029214-2017-00533. 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 MILD HEMIPLEGIA OCCURRED AFTER EMBOLIZATION IN ONE PATIENT WITH A LARGE AVM LOCATED IN THE ANTERIOR CENTRAL GYRUS AND ANOTHER PATIENT WITH A GIANT OCCIPITAL AVM HAD VISUAL FIELD DEFECT. BOTH UNDERWENT REHABILITATION CARE AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299081 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other