BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6655319 · Received June 20, 2017

    Report

    Report Number
    2029214-2017-00807
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    October 1, 2005
    Report Date
    July 26, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PIEROT L, JANUEL A-C, HERBRETEAU D, ET AL. MALFORMATIONS USING ONYX: RESULTS OF A PROSPECTIVE, MULTICENTER STUDY. JOURNAL OF NEURORADIOLOGY. 2009;36(3):147-152. DOI:10.1016/J.NEURAD.2008.11.005 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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

    ADDITIONAL INFORMATION RECEIVED: PIEROT L, JANUEL A-C, HERBRETEAU D, ET AL. MALFORMATIONS USING ONYX: RESULTS OF A PROSPECTIVE, MULTICENTER STUDY. JOURNAL OF NEURORADIOLOGY. 2009;36(3):147-152. DOI:10.1016/J.NEURAD.2008.11.005. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF ONYX FOR EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVM). A PROSPECTIVE, MULTICENTER STUDY WAS CONDUCTED IN FRANCE TO EVALUATE EMBOLIZATION OF BAVM WITH ONYX. FROM MAY 2003 TO MARCH 2005, 50 PATIENTS (26 FEMALES, 24 MALES; MEAN AGE: 34.8 YEARS, RANGE: 16¿64 YEARS) WERE INCLUDED. CLINICAL PRESENTATION WAS HEMORRHAGE IN 22 PATIENTS (44.0%), SEIZURES IN 16 PATIENTS (32.0%), HEADACHES IN SIX PATIENTS (12.0%) AND PROGRESSIVE NEUROLOGICAL DEFICIT IN TWO CASES (4.0%). FOUR PATIENTS WERE ASYMPTOMATIC (8.0%). PATIENTS HARBOURING BAVM TREATABLE BY ENDOVASCULAR APPROACH WERE INCLUDED IF THE TREATMENT WAS PARTIALLY OR COMPLETELY PERFORMED USING ONYX. ONE HUNDRED AND FORTY-NINE SESSIONS OF EMBOLIZATION WERE PERFORMED. ONE HUNDRED AND SIXTEEN SESSIONS (77.9%) WERE PERFORMED WITH ONYX, 20 SESSIONS (13.4%) WITH GLUE AND 13 SESSIONS (8.7%) WITH ONYX AND GLUE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -ACUTE POSTEMBOLIZATION HEMORRHAGE (APEH) WAS OBSERVED IN SEVEN PATIENTS. IN ALL CASES, APEH OCCURRED IN PATIENTS HARBORING BAVM TREATED IN SEVERAL SESSIONS OF EMBOLIZATION. IN FIVE CASES, HEMORRHAGE OCCURRED AFTER A SESSION OF ONYX TREATMENT, IN ONE CASE AFTER A SESSION OF GLUE TREATMENT AND IN ONE CASE AFTER A SESSION OF GLUE AND ONYX TREATMENT. IN ALL CASES, APEH OCCURRED IN THE HOURS FOLLOWING EMBOLIZATION. -IN THREE CASES, BLEEDING WAS NOT ASSOCIATED WITH ANY CLINICAL MODIFICATION. SYMPTOMATIC ACUTE POSTEMBOLIZATION HEMORRHAGE WAS ENCOU NTERED IN FOUR PATIENTS. IN TWO CASES, HEMATOMAS WERE SURGICALLY REMOVED. POSTOPERATIVELY BOTH PATIENTS HAD A SEVERE NEUROLOGICAL DEFICIT (MODIFIED RANKIN SCALE [MRS] = 5). THE OTHER TWO PATIENTS DID NOT UNDERGO SURGERY. ONE PATIENT HAD A MINOR NEUROLOGICAL DETERIORATION RELATED TO THE BLEEDING -NON HEMORRHAGIC DEFICITS WERE ENCOUNTERED IN FIVE PATIENTS, AFTER ONYX TREATMENT IN FOUR CASES AND AFTER ONYX AND GLUE TREATMENT IN ONE CASE. IN TWO PATIENTS POSTOPERATIVE DEFICIT WAS MILD (MRS1). IN THE OTHER THREE PATIENTS, POSTOPERATIVE MRS WAS 2, 3 AND 4, RESPECTIVELY. -THIRTY-DAY TREATMENT RELATED MORBIDITY (MRS 3 TO 5) WAS 8% (FOUR PATIENTS) -PERCENTAGE OF OCCLUSION WAS 100% IN FOUR CASES, 80 TO 99% IN 27CASES, 60 TO 79% IN 8 CASES AND LESS THAN 60% IN 9 CASES. OUT OF THE 44 PATIENTS WITH INCOMPLETE OCCLUSION AFTER EMBOLIZATION, 37 WERE PROPOSED FOR RADIOSURGERY. FOUR PATIENTS REFUSED A COMPLEMENTARY TREATMENT AND 3 PATIENTS WITH A CLINICAL WORSENING AFTER EMBOLIZATION WERE AT THE PRESENT TIME NOT PROPOSED FOR A COMPLEMENTARY TREATMENT. -PERFORATION OR DISSECTION OF THE FEEDING PEDICLE WITHOUT BLEEDING WAS OBSERVED IN SIX CASES.

    Additional Manufacturer Narrative · 1

    PIEROT, L. (2005). ENDOVASCULAR TREATMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS USING ONYX: PRELIMINARY RESULTS OF A PROSPECTIVE MULT ICENTER STUDY. INTERVENTIONAL NEURORADIOLOGY, 11(1_SUPPL), 159-164. DOI:10.1177/15910199050110S119. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE ONYX DURING USE. THE EVENTS OCCURRED IN THE PATIENTS AFTER ONYX EMBOLIZATION AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2017-00805, 2029214-2017-00806, 2029214-2017-00807, 2029214-2017-00808. 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 LITERATURE REVIEW FOUND REPORTS OF PATIENT COMPLICATIONS AFTER ONYX EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF ONYX IN THE EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS). THE AUTHORS REVIEWED 48 PATIENTS (25 FEMALE, 23 MALE, MEAN AGE 41 YEARS). THE ARTICLE STATES THAT ACUTE POST-EMBOLIZATION HEMORRHAGE WAS OBSERVED IN FOUR CASES IN THE HOURS FOLLOWING EMBOLIZATION. THREE PATIENTS UNDERWENT SURGICAL TREATMENT DUE TO THE HEMATOMA. NEUROLOGICAL DEFICIT WAS OBSERVED IN ALL THREE PATIENTS IN THE MONTHS FOLLOWING THE BLEEDING. NON-HEMORRHAGIC DEFICITS WERE ENCOUNTERED IN FOUR CASES: CEREBRAL ISCHEMIA IN THREE CASES AND SPINAL CORD ISCHEMIA IN ONE CASE. DEFICIT WAS TRANSIENT IN TWO CASES AND PERMANENT IN TWO CASES. IN FOUR CASES, PERFORATION OR DISSECTION OF THE FEEDING PEDICLE WITHOUT BLEEDING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435081 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O