BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6211827 · Received December 28, 2016

    Report

    Report Number
    2029214-2016-01150
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    January 1, 2006
    Report Date
    December 8, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX MATERIAL WAS NOT RETURNED AS IT WAS CONSUMED IN THE PROCEDURE; THEREFORE, PRODUCT ANALYSIS OF THE MATERIAL /DEVICE WAS NOT ABLE TO BE PERFORMED. DHR REVIEW AND LOT HISTORY REVIEW WERE NOT PERFORMED AS A MANUFACTURING RELATED CAUSE FOR THIS EVENT WAS NOT SUSPECTED. POST ONYX EMBOLIZATION OF A PERIPHERAL ARTERIOVENOUS MALFORMATION (AVM) THE PATIENT EXPERIENCED PAIN, ISCHEMIA AND A SKIN ULCER WITHIN THE TREATING VESSEL. THIS EVENT REQUIRED SURGICAL INTERVENTION. THE PATIENT WAS LEFT WITH A SCAR OF THE TREATING HAND/AREA. ISCHEMIA IS A KNOWN INHERENT RISK OF ENDOVASCULAR EMBOLIZATION PROCEDURE AND IS DOCUMENTED IN THE ONYX INSTRUCTION FOR USE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE/PRODUCT WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. MDR RELATED TO THIS EVENT: 2029214-2016-01149, 2029214-2016-01150. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE "TRANSARTERIAL EMBOLIZATION OF PERIPHERAL ARTERIOVENOUS MALFORMATIONS WITH ETHYLENE VINYL ALCOHOL COPOLYMER - FEASIBILITY, TECHNICAL OUTCOMES, AND CLINICAL OUTCOMES." PUBLISHED ONLINE SEPTEMBER 6, 2016 DOI: HTTP://DX.DOI .ORG/10.1024/0301-1526/A000571. VASA (2016), 45, PP. 497-504. 2016 HOGREFE AG. MAJOR COMPLICATIONS POST INTERVENTION OCCURRED IN A PATIENT WITH PERIPHERAL HAND AVM. THE PATIENT PRESENTED WITH ISCHEMIC SKIN ULCER NEAR THE SITE OF EMBOLIZATION. DUE TO AVM EMBOLIZATION OF BRANCHES ORIGINATING FROM THE FEEDING ARTERY, WITH SUBSEQUENTLY PERSISTENT PAIN SYMPTOMS AND WERE ULTIMATELY TREATED WITH SURGERY. LOCAL EXCISION OF THE SKIN ULCER AND 2ND DIGITAL AMPUTATION RELATED TO PERSISTENT LOCAL SKIN INFECTION AND ULCERATION UNRESPONSIVE TO CONSERVATIVE THERAPY. THIS ARTICLE REPORTS THAT THE ONYX MATERIAL WAS SHAKEN FOR AT LEAST 15 MINUTES. HOWEVER, PER THE IFU, THE ONYX SHOULD BE SHAKEN FOR 20 MINUTES AND CONTINUE MIXING UNTIL READY TO BE USED. THE INJECTION WAS TEMPORARILY STOPPED AS SOON AS REFLUX OF ONYX WAS OBSERVED 2 TO FIVE MINUTES LATER, THE INJECTION WAS RESTARTED. THE INJECTIONS WERE STOPPED IF THE ONYX REFLUX CREATED AN EXCESSIVE RISK OF NON-TARGET EMBOLIZATION. COMPETITOR EMBOLIC MATERIALS WERE AND ONYX WAS ALSO USED TO TREAT ADDITIONAL COLLATERAL BRANCHES. ONE DAY POST EMBOLIC PROCEDURE THE PATIENTS WERE DISCHARGED. TWENTY-TWO (22) PATIENTS TREATED (6 MALES/ 16 FEMALES), AGE RANGE WAS 2-76 (MEAN 37). ALL CASES WERE REPORTED TO HAVE BEEN ABLE TO INJECT ONYX SLOWLY INTO THE FEEDING ARTERIES WITHOUT MIGRATING INTO THE DRAINING VEINS. EIGHT (8) PATIENTS REPORTED TO HAVE COMPLETE OCCLUSION. FOURTEEN (14) PATIENTS HAD SUBTOTAL OCCLUSION OF THE NIDUS OWING TO PARTIAL FILLING OF THE NIDUS WITH ONYX. FIVE (5) OF THESE PATIENTS DID NOT HAVE COMPLETE OCCLUSION DESPITE THE USE OF COMPETITOR EMBOLIC MATERIALS. EIGHTEEN (18) OF THE 22 PATIENTS COMPLETELY HAD THE AVM DISAPPEARED OR THE MAJOR SYMPTOMS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858156 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention