BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX PV

    MDR report key: 6474548 · Received April 8, 2017

    Report

    Report Number
    2029214-2017-00399
    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 WHEN THE EMBOLIC MATERIAL ENCOUNTERED FORAMEN SPINOSUM. THE PATIENT RECEIVED MEDICATION WHICH WAS RESOLVED THE TCR AND IT 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.

    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 1 HAD A COGNARD TYPE IV LEFT TENTORIAL DAVF, SUPPLIED PREDOMINANTLY BY BRANCHES OF THE LEFT MIDDLE MENINGEAL AND OCCIPITAL ARTERIES. HER LESION WAS APPROACHED TRANS-ARTERIALLY VIA THE PETROUS BRANCH OF THE LEFT MIDDLE MENINGEAL ARTERY. THE MICROCATHETER WAS ADVANCED AS DISTALLY AS POSSIBLE, AND ONYX-18 WAS INJECTED GENTLY. DESPITE THE REFLUX-HOLD-REINJECTION TECHNIQUE, THERE WAS SIGNIFICANT RETROGRADE FLOW OF ONYX ALONG THE MICROCATHETER. WHEN THE REFLUXED ONYX CAST REACHED THE FORAMEN SPINOSUM, THE PATIENT WENT INTO SINUS ARREST WITH MARKED HYPOTENSION. THE INJECTION WAS STOPPED IMMEDIATELY AND 1 MG OF INTRAVENOUS (I.V.) ATROPINE ADMINISTERED. THE PATIENT¿S VITAL SIGNS RETURNED TO BASELINE WITHIN 30 TO 40 SECONDS; THE ONYX INJECTION WAS RESUMED UNTIL THE DAVF WAS COMPLETELY OCCLUDED. DURING THE REMAINDER OF THE PROCEDURE, THE TCR DID NOT RECUR. THE POST-OPERATIVE RECOVERY WAS UNEVENTFUL FOR THE PATIENT. AT THE 3- AND 6-MONTH FOLLOW-UP, THE PATIENTS WERE 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
    256382 ONYX PV AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7200-060

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention