BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17511191 · Received August 11, 2023

    Report

    Report Number
    2029214-2023-01360
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 28, 2015
    Report Date
    August 11, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AMULURU K, NGUYEN J, AL-MUFTI F, ET AL. SAFETY AND EFFECTIVENESS OF MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE USING SINGLE PLANE ANGIOGRAPHY. JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES: THE OFFICIAL JOURNAL OF NATIONAL STROKE ASSOCIATION. 2022;31(8):106553. DOI:10.1016/J.JSTROKECEREBROVASDIS.2022.106553. B.3. 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 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    SINGLA A, FARGEN KM, HOH B. ONYX EXTRUSION THROUGH THE SCALP AFTER EMBOLIZATION OF DURAL ARTERIOVENOUS FISTULA. JOURNAL OF NEUROINTE RVENTIONAL SURGERY. 2016;8(9):E38. DOI:10.1136/NEURINTSURG-2015-011879.REP. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX AND THE APOLLO CATHETER. THE PURPOSE OF THIS ARTICLE WAS TO REPORT A PATIENT WHO PRESENTED WITH SPONTANEOUS EXTRUSION OF ONYX FROM THE SCALP A FEW WEEKS AFTER EMBOLIZATION FOR A DURAL ARTERIOVENOUS FISTULA (DAVF). A MAN IN HIS SIXTIES WAS REFERRED WITH SYMPTOMS OF EPISODIC LEFT LIP NUMBNESS AND LEFT ARM WEAKNESS FOR FEW WEEKS. THERE WAS NO OTHER SIGNIFICANT PAST MEDICAL OR SOCIAL HISTORY. THE PATIENT WAS NEUROLOGICALLY INTACT ON EXAMINATION. OUTPATIENT CT ANGIOGRAM SHOWED ABNORMAL VESSELS IN THE RIGHT TEMPORAL LOBE SUSPICIOUS OF AN INTRACRANIAL VASCULAR MALFORMATION. HE UNDERWENT DSA WHICH REVEALED ABORDEN TYPE 3 DAVF. SUCCESSFUL ONYX-18 AND ONYX-34 EMBOLIZATION OF THE DAVF WAS PERFORMED VIA THE DISTAL LEFT OCCIPITAL ARTERY USING AN EV3 APOLLO DETACHABLE TIP MICROCATHETER, RESULTING IN OBLITERATION OF THE BILATERAL OCCIPITAL ARTERY SUPPLIES TO THE DAVF. THERE WAS STILL RESIDUAL DAVF SUPPLIED BY THE BILATERAL MIDDLE MENINGEAL ARTERIES AND THE RIGHT FALCINE ARTERY. DUE TO INCOMPLETE OBLITERATION VIA ENDOVASCULAR EMBOLIZATION, THE PATIENT UNDERWENT SURGICAL OBLITERATION OF THE DAVF 3 DAYS LATER. POSTOPERATIVELY THE PATIENT REMAINED NEUROLOGICALLY INTACT. THERE WAS NO ABNORMAL STAINING ON THE SCALP. HIS INCISION SITE REMAINED CLEAN, DRY, AND INTACT. HE WAS DISCHARGED HOME. THREE MONTHS LATER DURING A ROUTINE POSTOPERATIVE CLINIC VISIT, THE PATIENT PRODUCED A PLASTIC BAG CONTAINING MULTIPLE SMALL PIECES OF THE ONYX METALLIC CAST WHICH HE KEPT THAT HAD EXTRUDED OUT FROM HIS SCALP THROUGH SMALL SPONTANEOUS HOLES ABOUT 5 WEEKS AFTER THE PROCEDURE. ALONG WITH THE ONYX CASTS THE DETACHED TIP OF THE APOLLO MICROCATHETER HAD ALSO EXTRUDED. THESE AREAS OF SKIN EROSION WERE ABOUT AN INCH AWAY FROM THE SURGICAL INCISION SITE AND DID NOT RESULT IN WOUND COMPLICATIONS. THE SURGICAL INCISION SITE WAS COMPLETELY HEALED AT THE TIME OF THE CLINIC VISIT. HISTOPATHOLOGICAL STUDY SHOWED THAT ONYX EVOKED A MILD DEGREE OF INTRA AND PERIVASCULAR INFLAMMATION IN THE SUBACUTE (18 DAYS) AND CHRONIC (1¿6 MONTHS) PHASES AFTER EMBOLIZATION. GRANULOMATOUS INFLAMMATORY RESPONSE, INCLUDING MANY ELONGATED EPITHELIOID CELLS AS WELL AS SCATTERED FOREIGN BODY  GIANT CELLS, WAS SEEN IN THIS STUDY. NO INFLAMMATION WAS SEEN IN THE ACUTE PHASE. IT WAS BELIEVED THAT THE SPONTANEOUS EXTRUSION OF ONYX WAS SECONDARY TO THE INFLAMMATION FROM ONYX CAUSING EROSION OF THE VESSEL WALL AND SUBSEQUENTLY EROSION OF THE SKIN OF THE SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176253 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention