BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6474549 · Received April 8, 2017

    Report

    Report Number
    2029214-2017-00401
    Event Type
    Injury
    Date Received
    April 8, 2017
    Date of Event
    January 5, 2010
    Report Date
    March 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLIC MATERIAL WAS NOT RETURNED AS IT WAS CONSUMED IN THE INTERVENTION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. PER THE REPORTED INFORMATION, THE EVENT WAS CAUSED AT THE END OF PRIMING THE CATHETER. THE PATIENT RECEIVED MEDICATION WHICH WAS RESOLVED THE TCR WHICH DID NOT RECUR. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION OR DEFICIENCY BUT DOES APPEAR TO BE PROCEDURE RELATED, HOWEVER, ITS CAUSE CANNOT BE RELIABLY DETERMINED. MDR RELATED TO THIS EVENT: 2029214-2017-00399, 2029214-2017-00400, 2029214-2017-00401. 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

    CITATION: THE TRIGEMINOCARDIAC REFLEX IN ONYX EMBOLISATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULA. ONG CK1, ONG MT, LE K, POWER MA, WANG LL, LAM DV, PARKINSON RJ, WENDEROTH JD. J CLIN NEUROSCI. 2010 OCT;17(10):1267-70. DOI: 10.1016/J.JOCN.2010.01.041. EPUB 2010 JUL 15. TRIGEMINOCARDIAC REFLEX (TCR) WAS DEFINED AS ABRUPT BRADYCARDIA OF LESS THAN 60 BEATS/MINUTE AND HYPOTENSION WITH A DROP IN MEAN ARTERIAL BLOOD PRESSURE OF 20% OR MORE, DURING TRANSARTERIAL OR TRANSVENOUS INJECTION OF ONYX OR ITS SOLVENT, DIMETHYL-SULFOXIDE (DMSO). PATIENT 3 HAD A UNILATERAL CAVERNOUS SINUS DAVF, WITH AN OCCLUDED IPSILATERAL INFERIOR PETROSAL SINUS. GIVEN THIS, THE CAVERNOUS SINUS WAS ACCESSED VIA DIRECT PERCUTANEOUS TRANSORBITAL PUNCTURE THROUGH THE SUPERIOR ORBITAL FISSURE. TOWARDS THE END OF MICROCATHETER PRIMING WITH DMSO, THE PATIENT DEVELOPED SIGNIFICANT BRADYCARDIA WITH AN ABRUPT DROP OF ARTERIAL BLOOD PRESSURE. THE DMSO INJECTION WAS DECEASED IMMEDIATELY AND 1 MG OF ATROPINE GIVEN INTRAVENOUSLY. THE HAEMODYNAMIC PARAMETERS RETURNED TO NORMAL WITHIN 30¿40 SECONDS. THE EMBOLISATION WAS THEN RESUMED AND THE DAVF OBLITERATED, WITH NO FURTHER RECURRENCE OF THE TCR. THE POST-OPERATIVE RECOVERY WAS UNEVENTFUL FOR THE PATIENT. AT THE 3- AND 6-MONTH FOLLOW-UP, THE PATIENT WAS WELL AND SHOWED NO EVIDENCE OF ANY COMPLICATION THAT MIGHT HAVE BEEN RELATED TO THE INTRAOPERATIVE TCR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256383 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention