BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6697978 · Received July 10, 2017

    Report

    Report Number
    2029214-2017-00868
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    February 10, 2017
    Report Date
    June 20, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DEENA M. NASR, DO, WALEED BRINJIKJI, MD, MICHELLE J. CLARKE, MD, AND GIUSEPPE LANZINO, MD. CLINICAL PRESENTATION AND TREATMENT OUTCOMES OF SPINAL EPIDURAL ARTERIOVENOUS FISTULAS. J NEUROSURG SPINE 26:613¿620, 2017. HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2016.9.SPINE16618. THE PURPOSE OF THIS STUDY WAS TO REVIEW A CONSECUTIVE SERIES OF SPINAL EPIDURAL ARTERIOVENOUS FISTULAS (SEDAVFS) AND REPORT ON THE CLINICAL OUTCOMES, FUNCTIONAL STATUS, AND TREATMENT OUTCOMES. TWENTY-FOUR PATIENTS WITH SEDAVFS WERE INCLUDED IN THIS STUDY FROM 2005 TO 2015. THE PATIENTS MEAN AGE AT PRESENTATION WAS 66.9 YEARS; 15 PATIENTS WERE MALE. THE ONYX WILL NOT RETURN FOR EVALUATION AS IT REMAINS IN THE PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THE REPORTED EVENTS, HOWEVER NO RESPONSE HAS BEEN RECEIVED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE CAUSE OF THE REPORTED EVENT CANNOT BE RELIABLY DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. 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

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW, THAT OF 24 PATIENTS TREATED FOR SPINAL EPIDURAL ARTERIOVENOUS FISTULAS (SEDAVFS), 1 PATIENT EXPERIENCED A MINOR COMPLICATION OF A VERTEBRAL BODY INFARCT FOLLOWING ONYX EMBOLIZATION AND 1 PATIENT EXPERIENCED A SPINAL CORD INFARCTION FOLLOWING ENDOVASCULAR EMBOLIZATION WITH ONYX. THE PATIENT THAT EXPERIENCED A VERTEBRAL BODY INFARCT DID NOT EXPERIENCE ADDITIONAL DISABILITY OR CHANGE IN MANAGEMENT. THE PATIENT THAT EXPERIENCED SPINAL CORD INFARCT EXPERIENCED WORSENING OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479817 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability