BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6448580 · Received March 30, 2017

    Report

    Report Number
    2029214-2017-00292
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    January 1, 2009
    Report Date
    October 17, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GAO KUN, YANG XIN-JIAN, MU SHI-QING, ET AL. "EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS WITH ETHYLENE VINYL ALCOHOL COPOLYMER: TECHNICAL ASPECTS. CHINESE MEDICAL JOURNAL 2009;122(16):1851-1856. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE REPORTED INFORMATION THERE IS NO EVIDENCE TO SUGGEST A DEVICE DEFICIENCY. WITHOUT RETURN OF THE DEVICE WE ARE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENTS. HOWEVER, THE AUTHOR NOTED THAT THE ENTRAPMENT WAS DUE TO LONG INJECTION TIME AND REFLUX LENGTH. THE ONYX INSTRUCTIONS FOR USE INDICATES, "DO NOT ALLOW MORE THAN 1 CM OF ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE ONYX REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT." IN ADDITION, WE ARE UNABLE TO DEFINITIVELY DETERMINE CAUSE FOR THE POST PROCEDURE COMPLICATIONS. HOWEVER, NEUROLOGICAL DEFICIT IS A KNOW INHERENT RISK OF NEUROINTERVENTIONAL PROCEDURES AND ARE DOCUMENTED IN THE ONYX INSTRUCTION FOR USE. MDRS RELATED TO THIS REPORT: 2029214-2017-00292 2029214-2017-00293 2029214-2017-00294. 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 REVIEW OF LITERATURE THAT DURING ONYX EMBOLIZATION A MICROCATHETER WAS GLUED IN THE AVM OF 5 PATIENTS AND CUT OFF IN THE GROIN BECAUSE OF THE LONG INJECTION TIME AND REFLUX LENGTH. OF THESE FIVE PATIENTS, THREE EXHIBITED NO NEW NEUROLOGICAL DEFICIT, ONE PATIENT WITH TRANSIENT DIPLOPIA, AND ANOTHER PATIENT WITH TRANSIENT RIGHT HEMIPARESIS. DMSO COMPATIBLE CATHETERS WERE USED (ULTRAFLOW AND MARATHON) HOWEVER THE MODELS OF THE CATHETERS THAT WERE GLUED TO THE AVM WERE NOT PROVIDED. IN ADDITION, SIXTEEN PATIENTS EXHIBITED A NEW FOCAL NEUROLOGICAL DEFICIT (HEMIPARESIS, LIMB PARESIS APHASIA AND VISUAL DISTURBANCES) DURING THE IMMEDIATE POST OPERATIVE PERIOD. THE DEFICIT WAS TRANSIENT IN 10 CASES. OF THE PERMANENT DEFICITS, THREE OUT OF FIVE WERE ISCHEMIC AND TWO WERE HEMORRHAGIC. THE DEFICIT WAS DISABLING IN THREE PATIENTS. ACCORDING TO THE MODIFIED RANKIN SCALE (MRS), TWO PATIENTS WERE RATED AT MRS 5 AND ONE PATIENT WITH MRS 4 AFTER THE 2 YEAR FOLLOW UP. A TOTAL OF 115 PATIENT WITH BRAIN AVMS WERE TREATED BY ENDOVASCULAR EMBOLIZTION ALONE OR IN COMBINATION WITH RADIO SURGERY. A TOTAL OF 196 PROCEDURES WERE PERFORMED WITH A MEAN OF 1.7 PROCEDURES PER PATIENT. IN 175 (89.3%) OF THE EMBOLIZATION SESSIONS, ONYX 18 WAS USED (REDUCED DENSE VERSION THAT OFFERS BETTER NIDUS PENETRATION) AS THE SOLE EMBOLIC MATERIAL; IN 15 (7.6%) SESSIONS ONYX 18 AND N-BCA WAS USED; IN 6 (3.1%) SESSIONS, ONYX 34 WAS USEDIN THE EMBOLIZATION OF DIRECT FISTULAS; IN 3 CASES (1.5%) OF AVMS ACCOMPANIED BY FEEDER ANEURYSMS, A DETACHABLE COIL WAS EMPLOYED TO OCCLUDE THE ANEURYSMS. THIS COHORT WAS FROM SEPTEMBER 2003 TO NOVEMBER 2007, 115 PATIENTS (43 WOMEN AND 72 MEN, WITH A MEAN AGE OF 29 YEARS) WITH BAVMS WERE ENDOVASCULARLY TREATED WITH ONYX IN OUR DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230191 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability