BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX LES

    MDR report key: 6517628 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00531
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    May 31, 2005
    Report Date
    March 30, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CITATION: DONGLEI SONG, BING LENG,YUXIANG GU, WEI ZHU, BIN XU, XIECHENG CHEN, LIANGFU ZHOU. CLINICAL ANALYSIS OF 50 CASES OF BAVM EMBOLIZATION WITH ONYX, A NOVEL LIQUID EMBOLIC AGENT. INTERVENTIONAL NEURORADIOLOGY 11: 179-184, 2005. THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EMBOLIZATION TECHNIQUE USING ONYX TO TREAT CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS), AS WELL AS THE EFFICACY. BETWEEN SEPTEMBER 2003 AND MAY 2005, 50 PATIENTS WITH BAVMS WERE TREATED. THERE WERE 35 MEN AND 15 FEMALE PATIENTS WITH A MEAN AGE OF 28 YEARS. STAGED SESSIONS OF EMBOLIZATION WERE PLANNED FOR PARTIALLY OCCLUDED AVMS. THE AUTHORS CONCLUDE THAT ONYX HAS A UNIQUE AND DISTINCTIVE SUPERIORITY IN TREATING CEREBRAL AVMS. THE ONYX AND MICROCATHETERS ARE NOT EXPECTED TO RETURN FOR EVALUATION AS THESE EVENTS WERE REPORTED THROUGH LITERATURE REVIEW. THERE IS LIMITED PATIENT AND DEVICE INFORMATION AVAILABLE. THE ONYX INSTRUCTIONS FOR USE (IFU) ADVISES, "DO NOT ALLOW MORE THAN 1 CM OF ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE ONYX REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE." CATHETER ENTRAPMENT IS A KNOWN INHERENT RISK OF THIS PROCEDURE AND IS DOCUMENTED IN THE ONYX IFU. BASED ON THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NO RESPONSE HAS BEEN RECEIVED. SHOULD THE INFORMATION BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-00531, 2029214-2017-00532 MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00529, 2029214-2017-00530, 2029214-2017-00533. 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 A MICROCATHETER (ULTRAFLOW OR MARATHON) WERE LEFT IN 3 PATIENTS AFTER THE EMBOLIZATION PROCEDURE. THE PATIENTS WERE RECEIVING ONYX EMBOLIZATION TO TREAT BRAIN ARTERIO VENOUS MALFORMATIONS (AVMS). AFTER A 6F GUIDING CATHETER WAS INTRODUCED INTO THE INTERNAL CAROTID ARTERY OR VERTEBRAL ARTERY, A FLOW-DIRECTED MICROCATHETER COMPATIBLE WITH DMSO (ULTRAFLOW OR MARATHON) WAS NAVIGATED INTO THE NIDUS OF AVMS WITH THE HELP OF BLOOD FLOW AND/OR A GUIDEWIRE. ANGIOGRAPHY OF THE MICROCATHETER WAS PERFORMED TO CONFIRM A STABLE DISTAL TIP POSITION OF THE MICROCATHETER, CLEAR ANGIOARCHITECTURE OF THE NIDUS, AND VISIBLE DRAINAGE VEIN. ONYX 18 WAS INJECTED AFTER THE MICROCATHETER WAS FLUSHED BY 0.3 ML DMSO. INJECTION AS SLOW AS 0.10-0.15ML PER MINUTE. A GOOD WORKING PROJECTION WAS FOUND TO SEE THE REFLUX CLEARLY AND AN ACCEPTABLE LENGTH OF REFLUX WAS ESTIMATED AND MARKED UNDER FLUOROSCOPY. AFTER MULTIPLE ROUNDS OF INJECTION, REFLUX, AND WAITING, A REFLUX AS LONG AS 1.0 CM TO 1.5 CM COULD BE FORMED AT THE TIP OF THE MICROCATHETER. THE MICROCATHETER WAS ATTEMPTED TO BE IMMEDIATELY REMOVED IF REFLUX EXCEEDED 1.5-2.0 CM. WHEN THE CATHETER WAS WITHDRAWN, THE MICROCATHETER WAS PULLED STRAIGHT FIRST, THEN APPLIED WITH GRADUALLY INCREASED FORCE. HOWEVER, MICROCATHETERS WERE LEFT IN THE BODY OF 3 PATIENTS. THESE 3 PATIENTS WERE TREATED WITH LOW MOLECULE HEPARIN FOR ONE WEEK (FRAXIPARINE, 0.4 ML, I.M., BID). NO ADVERSE REACTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299078 ONYX LES AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR