BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4743711 · Received May 1, 2015

    Report

    Report Number
    2029214-2015-00489
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    December 1, 2007
    Report Date
    April 2, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/18077948. THIS REPORT WAS CREATED TO CAPTURE COMPLICATIONS RELATED TO ONYX FOR PATIENT 1. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00490 . (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM THIS ARTICLE REGARDING THE ULTRAFLOW HPC MICROCATHETER WAS CAPTURED IN MFR REPORT # 2029214-2006-00061.

    Description of Event or Problem · 1

    CITATION: ANDREW P. CARLSON, ET AL. TREATMENT OF DURAL ARTERIOVENOUS FISTULA USING ETHYLENE VINYL ALCOHOL (ONYX) ARTERIAL EMBOLIZATION AS THE PRIMARY MODALITY: SHORT-TERM RESULTS. PUBLISHED IN J NEUROSURGE 107: 1120-1125, DECEMBER, 2007. ONYX WAS INJECTED INTO PROXIMAL RIGHT MIDDLE MENINGEAL ARTERY (MMA) OF A PATIENT IN THE HOPE OF PUSHING THE MATERIAL THROUGH THE FISTULA, BUT THIS WAS UNSUCCESSFUL AS THE FISTULA CONTINUED TO FILL THROUGH THE LEFT (MMA). THE FOLLOWING DAY, A COMBINED TRANSVENOUS AND TRANSARTERIA APPROACH WAS USED FOR FURTHER EMBOLIZATION. TRANSVENOUS CATHETERIZATION OF THE ANTERIOR THIRD OF THE SUPERIOR SAGITTAL SINUS (SSS) WAS ACHIEVED, FOLLOWED BY REPEATED ARTERIAL CATHETERIZATION OF THE LEFT (MMA). MULTIPLE COILS WERE PLACED INTO THE (SSS) JUST PROXIMAL TO THE DURAL ARTERIOVENOUS FISTULA (DAVF) WHERE THERE WAS EVIDENCE OF PREVIOUS OCCLUSION AND RECANALIZATION. ONYX WAS THEN INJECTED INTO THE FISTULA AND FOUND TO FILL THE FISTULA AND CORTICAL VEINS. AT THIS POINT, FURTHER DETACHABLE COILS WERE PLACED INTO THE (SSS) DISTAL TO THE FISTULA. THE FISTULA CONTINUED TO FILL VIA A FALCINE BRANCH OF THE OPHTHALMIC ARTERY, ALTHOUGH THERE WAS NO REFLUX INTO CORTICAL VEINS. ATTEMPTS WERE MADE TO SELECTIVELY CATHETERIZE THIS VESSEL VIA THE LEFT OPHTHALMIC ARTERY; HOWEVER, DURING MANIPULATION OF THE CATHETER IN THIS VERY TORTUOUS VESSEL, THE TIP OF THE CATHETER WAS BROKEN. THE REMAINDER OF THE CATHETER WAS WITHDRAWN, AND ANGIOGRAPHY SHOWED CONTINUED ADEQUATE FILLING OF THE OPHTHALMIC ARTERY. NO NEW CLINICAL DEFICITS WERE NOTED, AND THE PATIENT REMAINED SEIZURE FREE. THE INTERNAL CAROTID ARTERY (ICA) AND EXTERNAL CAROTID ARTERY (ECA) ANGIOGRAMS AT 3 MONTHS SHOWED WEAK RESIDUAL FILLING OF THE (DAVF), PRESUMABLY VIA THE FALCINE BRANCH OF THE LEFT (ICA); HOWEVER, THE FISTULA ITSELF WAS TOO SMALL TO BE VISUALIZED. THE PATIENT WAS TREATED WITH GAMMA KNIFE SURGERY (GKS) FOR THE RESIDUAL (DAVF). OF NOTE, THE ONYX WAS NOT THOUGHT TO INTERFERE WITH GKS PLANNING. CLINICALLY, THE PATIENT DID NOT HAVE ANY FURTHER HEADACHES, BUT COMPLAINED OF INTERMITTENT DIPLOPIA. FOR ARTERIAL EMBOLIZATION, ONYX DELIVERED VIA A MARATHON OR AN ULTRAFLOW MICROCATHETER (BOTH EV3 NEUROVASCULAR). THE MARATHON CATHETER WAS USED PREFERENTIALLY BECAUSE OF THE DURABILITY OF ITS NITINOLBRAIDED TIP; HOWEVER, THIS CATHETER PROVED TOO INFLEXIBLE TO MANEUVER IN SEVERAL VESSELS PROMPTING USE OF THE ULTRAFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287816 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S