BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 7844180 · Received September 4, 2018

    Report

    Report Number
    2029214-2018-00773
    Event Type
    Injury
    Date Received
    September 4, 2018
    Report Date
    September 4, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    H060003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX LIQUID EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED IN THE PROCEDURE. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE INSTRUCTION FOR USE (IFU): "INDICATIONS FOR USE: PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). NOT FOR USE WITH PREMATURE INFANTS (1,500 G) OR INDIVIDUALS WITH SIGNIFICANT LIVER AND KIDNEY FUNCTION IMPAIRMENT. PERFORMING EMBOLIZATION TO OCCLUDE BLOOD VESSELS IS A HIGH RISK PROCEDURE. THIS DEVICE SHOULD BE USED ONLY BY PHYSICIANS WITH NEURO-INTERVENTIONAL TRAINING AND A THOROUGH KNOWLEDGE OF THE PATHOLOGY TO BE TREATED, ANGIOGRAPHIC TECHNIQUES, AND SUPER-SELECTIVE EMBOLIZATION. AVM EMBOLIZATION MAY INFLUENCE BLOOD FLOW PATTERNS, THEREBY SUBJECTING ARTERIES SUPPLYING THE AVM OR THE BRAIN PROXIMAL TO THE AVM TO INCREASED PRESSURES. INCREASED ARTERIAL PRESSURES COULD RESULT IN HEMORRHAGIC COMPLICATIONS. THERAPEUTIC EMBOLIZATION SHOULD NOT BE PERFORMED WHEN HIGH BLOOD FLOW PRECLUDES SAFE INFUSION OF THE EMBOLIC AGENT. ADEQUATE FLUOROSCOPIC VISUALIZATION MUST BE MAINTAINED DURING THE ONYX¿ LES DELIVERY OR NON-TARGET VESSEL EMBOLIZATION MAY RESULT. IF VISUALIZATION IS LOST AT ANY TIME DURING THE EMBOLIZATION PROCEDURE, HALT THE ONYX¿ LES DELIVERY UNTIL ADEQUATE VISUALIZATION IS RE-ESTABLISHED." MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH A PRESENTED CASE STUDY AT THE ¿FAILURE ANALYSIS ADVISORY COUNCIL¿ CONFERENCE IN (B)(6). THE PATIENT WAS DUPLEX (DOUBLE) WITH LEFT RENAL ARTERY STENOSIS AND A HISTORY OF ABPM AND ULCERATIVE PLAQUE. DURING A PROCEDURE TO ATTEMPT TO STENT VIA GUIDEWIRE THE PATIENT BECAME HYPOTENSIVE WITH AND FLANK PAIN. A CT SCAN IDENTIFIED BLEEDING IN KIDNEY. THEREFORE, ONYX WAS USED TO STOP THE BLEEDING. THE PATIENT IMPROVED, BUT ONYX MAY HAVE DECREASED BLOOD CIRCULATION TO THE KIDNEY, WHICH LEAD TO LOSS OF KIDNEY FUNCTION. ONE KIDNEY LEFT, 4 WEEKS LATER THE PATIENT PRESENTED WITH FEVER AND FLANK PAIN. THE REMAINING KIDNEY HAS PUS-ED OUT AND NEEDS NEPHRECTOMY. THEN WENT INTO ACUTE RENAL FAILURE (ARF) AFTER THE NEPHRECTOMY. ON FURTHER IMAGING, IT WAS IDENTIFIED THAT THE RIGHT RENAL ARTERY HAD ONYX IN IT, EVEN THOUGH ONYX TREATMENT WAS ORIGINALLY ON THE LEFT SIDE. PRESUMPTION IS THAT DURING SURGERY, WITH SOME MANIPULATION OF LEFT KIDNEY STENT AND ONYX, CAUSED THE ONYX TO SEEP TO RIGHT RENAL ARTERY. PER THE REPORTING PHYSICIAN, THE RENAL ARTERY STENOSIS (RAS) WAS NOT SEVERE INITIALLY, NOW THE PATIENT HAS COMPLETE LOSS OF RENAL FUNCTION. THE RENAL ARTERY (RA) MEASURED 5.3 MM, STENT PLACED WAS 5 MM, TOO SMALL. NOT DEEMED RELATED TO PRODUCT DEFECT, BUT THE ISSUE WAS CAUSED BY THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684442 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability