BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6788759 · Received August 11, 2017

    Report

    Report Number
    2029214-2017-00965
    Event Type
    Injury
    Date Received
    August 11, 2017
    Report Date
    July 19, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIQUID EMBOLIC MATERIAL WAS NOT RETURNED AS IT WAS CONSUMED IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. BASED ON THE PHOTOS AND REPORTED INFORMATION, THE EVENT OF MIGRATION AFTER EMBOLIZATION WAS CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THERE MAY HAVE BEEN INADEQUATE FLUOROSCOPIC VISUALIZATION OR THAT THE CATHETER MAY NOT HAVE BEEN PULLED GENTLY TO SEPARATE THE LIQUID EMBOLIC MATERIAL WHICH MAY HAVE LED TO THE REPORTED ISSUE. PER OUR INSTRUCTIONS FOR USE (IFU): ADEQUATE FLUOROSCOPIC VISUALIZATION MUST BE MAINTAINED DURING LIQUID EMBOLIC MATERIAL DELIVERY OR NON-TARGET VESSEL EMBOLIZATION MAY RESULT. IF VISUALIZATION IS LOST AT ANY TIME DURING THE EMBOLIZATION PROCEDURE, HALT LIQUID EMBOLIC MATERIAL DELIVERY UNTIL ADEQUATE VISUALIZATION IS RE-ESTABLISHED. UPON COMPLETION OF LIQUID EMBOLIC MATERIAL INJECTION, WAIT A FEW SECONDS, SLIGHTLY ASPIRATE SYRINGE, AND THEN GENTLY PULL THE CATHETER TO SEPARATE THE LIQUID EMBOLIC MATERIAL CAST. 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.

    Description of Event or Problem · 1

    CITATION: "REVASCULARIZATION OF ONYX INDUCED INTRA-OPERATIVE OCCLUSION OF VERTEBRO-BASILAR ARTERY USING THE MERCI DEVICE" SHON G. MICHAEL Æ AMAR S. SWARNKAR ÆJULIUS GENE S. LATORRE Æ TARAKAD S. RAMACHANDRAN Æ YAHIA M. LODI. NEUROCRIT CARE (2010) 12:269¿271 MEDTRONIC RECEIVED INFORMATION THAT DURING THE LIQUID EMBOLIC EMBOLIZATION PROCEDURE FOR A LEFT SIDE CEREBELLAR PEDUNCLE AREA HEMORRHAGE DUE TO AN ARTERIOVENOUS MALFORMATION (AVM), A RETROGRADE FLOW OF LIQUID EMBOLIC MATERIAL INTO THE BASILAR ARTERY WAS OBSERVED. THE RIGHT VERTEBRA-BASILAR JUNCTION WAS OCCLUDED PRESUMED TO BE IATROGENICALLY CAUSED BY THE LIQUID EMBOLIC MATERIAL REFLUX. A RETRIEVAL DEVICE WAS USED TO REMOVED THE LIQUID EMBOLIC MATERIAL. A POST PROCEDURAL ANGIOGRAM CONFIRMED COMPLETE RECANALIZATION OF THE OCCLUDED ARTERY. THE PATIENT'S PREVIOUS SYMPTOMS INCLUDED MILD RIGHT HEMIPARESIS, NYSTAGMUS, AND RIGHT SIDED DYSMETRIA. POST OPERATIVELY, THE PATIENT HAD A LEFT FACIAL PALSY AND PTOSIS AND MILD HEMIPARESIS. THE ARTICLE SUGGESTED THE NEW SYMPTOMS WERE CONSISTENT WITH ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) DISTRIBUTION BRAIN STEAM STROKE ASSOCIATED WITH LIQUID EMBOLIC MATERIAL. THIS PATIENT'S 90-DAY FOLLOW UP SHOWN AN IMPROVEMENT FROM NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 8 TO 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567555 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention