BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 16312575 · Received February 7, 2023

    Report

    Report Number
    2029214-2023-00195
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    June 30, 2022
    Report Date
    February 7, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SI-MOHAMED SA, CIERCO A, GAMONDES D, ET AL. EMBOLIZATION OF RECURRENT PULMONARY ARTERIOVENOUS MALFORMATIONS BY ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) IN HEREDITARY HEMORRHAGIC TELANGIECTASIA: SAFETY AND EFFICACY. JOURNAL OF PERSONALIZED MEDICINE. 2022;12(7):1091. DOI:10.3390/JPM12071091 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

    SI-MOHAMED SA, CIERCO A, GAMONDES D, ET AL. EMBOLIZATION OF RECURRENT PULMONARY ARTERIOVENOUS MALFORMATIONS BY ETHYLENE VINYL ALCOHOL COPOLYMER (ONYX) IN HEREDITARY HEMORRHAGIC TELANGIECTASIA: SAFETY AND EFFICACY. JOURNAL OF PERSONALIZED MEDICINE. 2022;12(7):1091. DOI:10.3390/JPM12071091. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE SHORT- AND LONG-TERM SAFETY AND EFFICACY OF EMBOLIZATION WITH ONYX FOR RECURRENT PULMONARY ARTERIOVENOUS MALFORMATIONS (PAVMS) IN HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT). THERE WERE 45 PATIENTS (51% WOMEN, MEAN AGE 53 YEARS) WITH HHT REFERRED TO A REFERENCE CENTER FOR TREATMENT OF RECURRENT PAVM THAT WERE INCLUDED IN THE STUDY. THIS CONSISTED OF 70 EMBOLIZATION PROCEDURES. ALL PROCEDURES WERE TECHNICALLY SUCCESSFUL, WITH A SHORT-TERM OCCLUSION RATE OF 100%. NO IMMEDIATE COMPLICATION DIRECTLY RELATED TO EMBOLIZATION WAS REPORTED, NOR WAS ANY SEVERE LONG-TERM COMPLICATION SUCH AS STROKES OR CEREBRAL ABSCESSES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - UPSTREAM LEAKS IN THE SUB-SEGMENTAL ARTERIES WERE REPORTED IN 39 (56%) PAVMS AND IN THE SEGMENTAL ARTERIES IN 4 (6%) PAVMS. NO DOWNSTREAM LEAK IN THE ANEURYSMAL SAC OR IN THE EFFERENT VEIN OR UPSTREAM LEAK IN THE HEALTHY LOBAR ARTERIES WAS REPORTED. THEY AVOIDED DOWNSTREAM LEAKAGES BY STOPPING THE PROCEDURE WHEN ONYX WOULD GO PAST THE MATERIALS, WHICH OCCURRED IN 19% OF CASES. THE PROCEDURE WAS ALSO STOPPED WHEN ONYX WOULD GO UPSTREAM OF THE PRE-IMPLANTED EMBOLIC MATERIAL IN A HEALTHY ARTERIAL BRANCH. A CONTINUOUS ONYX INJECTION WAS USED UNTIL THE ENDPOINT WAS REACHED. NEVERTHELESS, IN 69% OF CASES, AN UPSTREAM LEAK IN A NONINVOLVED ARTERIAL BRANCH WAS REPORTED, WHICH OPENS TO INJECTION TECHNIQUES UNDER FLOW CONTROL. DESPITE THIS HIGH PROPORTION, ONLY 29% OF THESE CASES PRESENTED A PERFUSION DEFECT ON PULMONARY ANGIOGRAPHY, FROM WHICH ONLY 4% OF THE PATIENTS REPORTED A DISTAL LUNG INFARCTION, WHICH WAS QUASI-ASYMPTOMATIC AND RESOLVED SPONTANEOUSLY.  - LUNG INFARCTIONS WERE REPORTED IN THREE (7%) PATIENTS. THEY RESOLVED SPONTANEOUSLY WITHOUT REQUIRING LONGER HOSPITALIZATION OR LEVEL 3 ANALGESICS EXCEPT FOR ONE PATIENT FOR WHOM IT WAS SYMPTOMATIC WITH A 3-DAY HOSPITALIZATION.  - THERE WERE 20 (29%) PERFUSION DEFECTS WERE REPORTED IN SUB-SEGMENTAL TERRITORIES.  - THE LONG-TERM OCCLUSION RATE WAS 60%.  - SIX PAVMS WERE TREATED A SECOND TIME BECAUSE OF AN ITERATIVE RECURRENCE AFTER A MEAN PERIOD OF 1.9 YEARS.  - HEMOPTYSIS DUE TO SYSTEMIC RECRUITMENT OF THE BRONCHIAL ARTERIES FROM THE PAVM WAS REPORTED IN TWO CASES, 3.5 YEARS AFTER RETREATMENT BY ONYX IN THE FIRST CASE, RELATED TO THE SYSTEMIC REPERFUSION OF A PAVM TREATED WITH COILS ONLY FOR THE SECOND CASE. BOTH WERE TREATED BY EMBOLIZATION USING COILS IN THE BRONCHIAL TERRITORIES.  - ONE PATIENT EXPERIENCED CHEST PAIN.  - A MILD ANAPHYLACTIC REACTION WAS REPORTED DURING THE PULMONARY ANGIOGRAPHY, WHICH DID NOT REQUIRE THE ARREST OF THE PROCEDURE.  - ALL PATIENTS EXPERIENCED A GARLIC SMELL FOLLOWING THE DIMETHYL SULFOXIDE INJECTION FOR A COUPLE OF DAYS, WITH NO OTHER SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114434 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization| R