BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 13588279 · Received February 23, 2022

    Report

    Report Number
    2029214-2022-00283
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    April 1, 2019
    Report Date
    February 23, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DAS GUPTA, J., RANA, M. A., MCGREW, P., DELU, A., GULIANI, S., AMP; MAREK, J. (2019). ISCHEMIC LUMBOSACRAL PLEXOPATHY AFTER E XTENSIVE ONYX ARTERIAL EMBOLIZATION FOR TYPE 2 ENDOLEAK. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 30(4), 619¿621. HTTPS://DOI.ORG/10.1016/J.JVIR.2018.09.025. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DATE IS MONTH/YEAR VALID. OPERATOR OF DEVICE: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DAS GUPTA, J., RANA, M. A., MCGREW, P., DELU, A., GULIANI, S., AMP; MAREK, J. (2019). ISCHEMIC LUMBOSACRAL PLEXOPATHY AFTER E XTENSIVE ONYX ARTERIAL EMBOLIZATION FOR TYPE 2 ENDOLEAK. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 30(4), 619¿621. HTTPS://DOI.ORG/10.1016/J.JVIR.2018.09.025. SUMMARY: LIQUID EMBOLIC AGENTS CAN BE USED AS A PRIMARY EMBOLIC AGENT OR ADJUNCT TO COIL EMBOLIZATION FOR TREATMENT OF TYPE 2 ENDOLEAKS. ETHYLENE-VINYL-ALCOHOL COPOLYMER (EVOH) OR ONYX (EV3 INC, IRVINE, CALIFORNIA) IS A POPULAR NONADHESIVE LIQUID EMBOLIC AGENT DUE TO THE SLOW AND CONTROLLED MANNER THE GLUE IS DELIVERED (1). THIS REPORT, WHICH MET THE INSTITUTIONAL REVIEW BOARD¿S CRITERIA FOR EXEMPTION APPROVAL, DISCUSSES A PATIENT WHO UNDERWENT EXTENSIVE NONSELECTIVE ONYX EMBOLIZATION FOR A TYPE 2 ENDOLEAK AND DEVELOPED ISCHEMIC PERIPHERAL LUMBOSACRAL PLEXOPATHY. THE PATIENT WAS A (B)(6) MALE WITH A PAST MEDICAL HISTORY OF HEPATITIS C AND THROMBOCYTOPENIA WHO UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) FOR A 6.1-CM INFRARENAL AORTIC ABDOMINAL ANEURYSM. FOURTEEN MONTHS POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SHOWED AN ANEURYSM SAC OF 6.8 CM WITH EVIDENCE OF A TYPE 2 ENDOLEAK ARISING FROM A PATENT INFERIOR MESENTERIC ARTERY (IMA) AND A PAIR OF LUMBAR ARTERIES (FIG A). SELECTIVE SUPERIOR MESENTERIC ARTERY ARTERIOGRAM REVEALED A MEANDERING MESENTERIC ARTERY THAT RETROGRADE FILLED A PATENT IMA AND THE AORTIC SAC. THE ANEURYSM SAC WAS UNABLE TO BE CANNULATED AND UNDERWENT COIL EMBOLIZATION OFF THE ORIGIN OF THE IMA. COMPLETION ARTERIOGRAM REVEALED PLACEMENT OF THE COILS AS TARGETED. LUMBAR ARTERIAL COLLATERALS WERE NOTED TO BE FILLING THE ANEURYSMAL SAC, BUT ACCESS AND PATH COULD NOT BE IDENTIFIED. IDENTIFIED EVENTS: 1. IN TOTAL, 10 VIALS OF 1.5 ML OF ONYX WERE INJECTED THROUGH THE MICROCATHETER, WITH 2 VIALS BEING ONYX 34 (8% OF EVOH) AND THE REST BEING ONYX 18 (6% OF EVOH) INTO THE PATIENT. THE PATIENT¿S FIRST NEUROLOGICAL EXAM WAS NOTED TO HAVE SIGNIFICANT PARESIS OF HIS HIP FLEXORS AND KNEE EXTENSORS OF HIS LEFT LEG, ALONG WITH SENSORY DEFICITS CONSISTENT WITH ISCHEMIC PERIPHERAL LUMBOSACRAL PLEXOPATHY. THE PATIENT REMAINED ON BEDREST FOR 72 HOURS WITH INDUCED HYPERTENSION AND LUMBAR DRAINAGE. THE PATIENT HAD ALMOST COMPLETE RETURN OF SENSATION OF HIS LEFT LOWER EXTREMITY BUT CONTINUED TO HAVE WEAKNESS OF HIS LEFT QUADRICEPS. HE WAS DISCHARGED TO A REHABILITATION CENTER ON POSTOPERATIVE DAY 10 TO CONTINUE PHYSICAL THERAPY. SIX-MONTH POSTOPERATIVE CT SCAN SHOWED NO EVIDENCE OF A PERSISTENT ENDOLEAK, AND THE PATIENT REMAINED DEPENDENT ON A CANE FOR AMBULATION WITH DIFFICULTY OF FORWARD FLEXION OF HIS LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080280 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention