BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6742713 · Received July 25, 2017

    Report

    Report Number
    2029214-2017-00921
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 23, 2017
    Report Date
    March 2, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ORLOV, K., GORBATYKH, A., BERESTOV, V., SHAYAKHMETOV, T., KISLITSIN, D., SELEZNEV, P., AND STRELNIKOV, N. (2017). SUPE RSELECTIVE TRANSVENOUS EMBOLIZATION WITH ONYX AND N-BCA FOR VEIN OF GALEN ANEURYSMAL MALFORMATIONS WITH RESTRICTED TRANSARTERIAL ACCESS: SAFETY, EFFICACY, AND TECHNICAL ASPECTS. CHILDS NERVOUS SYSTEM. DOI:10.1007/S00381-017-3499-6. THE PURPOSE OF THIS ARTICLE WAS TO STUDY SUPERSELECTIVE TRANSVENOUS EMBOLIZATION (TVE) WITH LIQUID EMBOLIC AGENTS TO TREAT VEIN OF GALEN ANEURYSMAL MALFORMATIONS (VGAM). BETWEEN JANUARY 2011 AND MAY 2016 27 PATIENTS UNDERWENT 53 SESSIONS OF VGAM EMBOLIZATION. OF THEM, TEN PATIENTS UNDERWENT TRANSVENOUS EMBOLIZATION DURING ONE OF THE TREATMENT SESSIONS DUE TO RESTRICTED TRANSARTERIAL ACCESS. THE PATIENTS AGE RANGED FROM 4 TO 51 MONTHS; 8 WERE MALE. THERE WAS NO PROCEDURE-RELATED PERMANENT MORBIDITY OR MORTALITY. THE AUTHORS CONCLUDE THAT TVE WITH LIQUID EMBOLIC AGENTS IS A SAFE AND EFFECTIVE SALVAGE METHOD FOR VGAMS WITH RESTRICTED TRANSARTERIAL ACCESS. THERE WAS NO PERMANENT MORBIDITY, OR MORTALITY ASSOCIATED WITH TRANSVENOUS EMBOLIZATION. THE ONYX WAS NOT RETURNED FOR ANALYSIS AS THESE EVENTS WERE DISCOVERED VIA LITERATURE REVIEW; THEREFORE, PRODUCT ANALYSIS OF THE ONYX DEVICE WAS NOT ABLE TO BE PERFORMED. THERE IS NO EVIDENCE SUGGESTING THE ONYX WAS DEFECTIVE. THE ONYX IFU NOTES, ¿HEMODYNAMIC CHANGES INDUCTED BY THE EMBOLIZATION MAY RESULT IN HEMORRHAGIC COMPLICATIONS.¿ THE CAUSE OF THE REPORTED EVENTS CANNOT BE RELIABLY DETERMINED, HOWEVER, BASED ON THE INFORMATION ON THIS CASE, AND REVIEW OF THE ARTICLE, AND IFU, THE LIKELY CAUSE OF THE REPORTED EVENTS IS PROCEDURE RELATED. 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

    THE EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS, AS IT WAS CONSUMED THE INTERVENTION. HEMODYNAMIC CHANGES INDUCTED BY THE EMBOLIZATION MAY RESULT IN NEUROLOGICAL COMPLICATIONS. THE CAUSE OF THE REPORTED EVENTS CANNOT BE RELIABLY DETERMINED, HOWEVER, BASED ON THE INFORMATION ON THIS CASE, AND REVIEW OF THE ARTICLE, AND IFU, THE LIKELY CAUSE OF THE REPORTED EVENTS IS PROCEDURE RELATED. 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 ONE PATIENT EXPERIENCED AN INTRAVENTRICULAR HEMORRHAGE AFTER THE SECOND ONYX EMBOLIZATION PROCEDURE AND WAS TREATED WITH EXTERNAL VENTRICULAR DRAINAGE. THIS PATIENT WENT ON TO SUCCESSFUL ANGIOGRAPHIC CURE IN FOLLOW UP EMBOLIZATION. THE PATIENT WAS RECEIVING TREATMENT FOR CHOROIDAL VEIN OF GALEN ANEURYSMAL MALFORMATION (VGAM).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT POST THE EMBOLIZATION PROCEDURE, ONE PATIENT SHOWED FOCAL EDEMA IN THE RIGHT POSTERIOR THALAMUS, ADJACENT TO THE EMBOLIC CAST WHICH RESOLVED AFTER 4 DAYS AND DEXAMETHASONE WAS ADMINISTERED INTRAVENOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521636 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention