BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM

    MDR report key: 14034270 · Received April 6, 2022

    Report

    Report Number
    2029214-2022-00595
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    July 23, 2021
    Report Date
    April 6, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO REGULATORY REPORT# 2029214-2022-00594 FOR RELATED INFORMATION. ZHAO R, DUAN G, YANG P, LI T, GUAN S, YANG H, ZHAO Z, ZHU X, LIANG G, WU X, LENG B, WANG Y, WU Y, ZUO Q, ZHANG L, LI Z, ZHOU Y, ZHAO K, DAI D, FANG Y, LI Q, HUANG Q, HONG B, XU Y, LIU J. (2021). ENDOVASCULAR ANEURYSM TREATMENT WITH THE NUMEN COIL EMBOLIZATION SYSTEM: A PROSPECTIVE RANDOMIZED CONTROLLED OPEN-LABEL MULTICENTER NONINFERIORITY TRIAL IN CHINA. WORLD NEUROSURGERY, E1-E10. HTTPS://DO I.ORG/10.1016/J.WNEU.2021.11.067. AGE AND SEX REPRESENT THE MAJORITY OF THE PARTICIPANTS IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ZHAO R, DUAN G, YANG P, LI T, GUAN S, YANG H, ZHAO Z, ZHU X, LIANG G, WU X, LENG B, WANG Y, WU Y, ZUO Q, ZHANG L, LI Z, ZHOU Y, ZHAO K, DAI D, FANG Y, LI Q, HUANG Q, HONG B, XU Y, LIU J. (2021). ENDOVASCULAR ANEURYSM TREATMENT WITH THE NUMEN COIL EMBOLIZATION SYSTEM: A PROSPECTIVE RANDOMIZED CONTROLLED OPEN-LABEL MULTICENTER NONINFERIORITY TRIAL IN CHINA. WORLD NEUROSURGERY, E1-E10. HTTPS://DO I.ORG/10.1016/J.WNEU.2021.11.067 THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF THE NUMEN COIL COMPARED WITH THE AXIUM COIL IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. BETWEEN AUGUST 2017 AND DECEMBER 2019, 350 PATIENTS PRESENTING WITH 350 ANEURYSMS WERE ENROLLED AND RANDOMIZED. PER-PROTOCOL ANALYSIS SHOWED THAT THE SUCCESSFUL ANEURYSM OCCLUSION RATE AT 6 MONTHS WAS 91.18% FOR THE TEST GROUP COMPARED WITH 91.85% IN THE CONTROL GROUP, WITH A DIFFERENCE OF E0.68% (P [ 0.8419), AND THE OVERALL MORTALITY DURING THE 30-DAY FOLLOW-UP PERIOD WAS 1.19% AND 1.81% IN THE TEST AND CONTROL GROUP, RESPECTIVELY,SHOWING NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P [ 0.6837), WHEREAS THE SAE INCIDENCE DURING THE 12-MONTH FOLLOW-UP PERIOD WAS 12.50% AND 17.47% IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, WHICH WAS NOT STATISTICALLY SIGNIFICANT (P [ 0.2222). THIS TRIAL SHOWED THAT THE NUMEN COIL WAS NONINFERIOR TO THE AXIUM COIL IN TERMS OF INTRACRANIAL ANEURYSM EMBOLIZATION AND CAN BE CONSIDERED AS A SAFE AND EFFECTIVE COIL FOR TREATING PATIENTS WITH INTRACRANIAL ANEURYSM IN CLINICAL PRACTICE. OF 350 PATIENTS PRESENTING WITH 350 ANEURYSMS ENROLLED AND RANDOMIZED BETWEEN AUGUST 8, 2017 AND DECEMBER 21, 2019, 5 WITHDREW CONSENT AND 11 VIOLATED THE TRIAL PROTOCOL AND DID NOT UNDERGO THE PROCEDURE, WHEREAS THE REMAINING 334 PATIENTS UNDERWENT ALL NECESSARY PROCEDURES (NUMEN, N ¼ 168; AXIUM, N ¼ 166), AND FORMED OUR FAS AND SS SUBGROUPS BASED ON A MODIFIED INTENTION-TO-TREAT PRINCIPLE. AMONG ALL 334 TREATED PATIENTS, 271 WERE INCLUDED IN THE PPS WHEREAS 54 WERE LOST TO THE PRIMARY END POINT FOLLOW-UP, 5 EXCEEDED THE 6 MONTHS FOLLOW-UP TIME, AND 4 WERE DEEMED INELIGIBLE BECAUSE 3 IN THE TEST GROUP WERE TREATED WITH THE AXIUM COIL AND 1 IN THE CONTROL GROUP DID NOT USE THE AXIUM COIL; A COMPARISON OF THE BASELINE CHARACTERISTICS BETWEEN THE 2 GROUPS IN THE FAS SHOWED SIMILAR DISTRIBUTIONS. THE AUTHORS REVIEWED 166 CASES OF PATIENTS TREATED FOR ANEURYSMS USING AXIUM COILS. OF THE 166 PATIENTS, THE AVERAGE AGE WAS 56 YEARS, 108 WERE FEMALE AND 58 WERE MALE. AT 6 MONTHS FOLLOW-UP, 2 PATIENTS IN THE CONTROL GROUP ACCEPTED RETREATMENT (2/160, 1.25%) WHEREAS RETREATMENT WAS NOT REQUIRED IN THE TEST GROUP AND THUS, NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE 2 GROUPS (P ¼ 0.2431); AT THE 12 MONTHS FOLLOW-UP, 2 PATIENTS IN THE CONTROL GROUP ACCEPTED RETREATMENT (2/156, 1.28%) AND RETREATMENT WAS NOT REQUIRED IN THE TEST GROUP, AND HENCE, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.2460). CLINICAL FOLLOW-UP DATA AT 6 MONTHS WERE AVAILABLE FOR 330 PATIENTS; THE CLINICAL OUTCOME WORSENING RATE FOR THE TEST GROUP WAS 3.01% (5/166) COMPARED WITH 4.88% (8/164) IN THE AXIUM CONTROL GROUP, THUS SHOWING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.3836), WHEREAS IN THE CLINICAL FOLLOW-UP DATA AT 12 MONTHS AVAILABLE FOR 319 PATIENTS, THE CLINICAL OUTCOME WORSENING RATE WAS 2.50% (4/160) FOR THE TEST GROUP COMPARED WITH 5.03% (8/159) IN THE AXIUM CONTROL GROUP, SHOWING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.2348). ALTHOUGH 19 PATIENTS WERE PRESENT IN THE TEST GROUP WITH AN INCIDENCE OF 10.71% AND 22 PATIENTS IN THE CONTROL GROUP WITH AN INCIDENCE OF 13.25% DURING THE 12 MONTHS FOLLOW-UP PERIOD BECAUSE OF PROCEDURE-RELATED ADVERSE EVENTS, THE DIFFERENCE BETWEEN THE 2 GROUPS WAS NOT STATISTICALLY SIGNIFICANT (P ¼ 0.6201). THE INCIDENCE OF SAES DURING THE 12 MONTHS FOLLOW-UP PERIOD WAS 12.50% (21/168) AND 17.47% (29/166) IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, THEREBY SUGGESTING THAT NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS NOTED BETWEEN THE 2 GROUPS (P ¼ 0.2222). SIMILARLY, THE INCIDENCE OF PROCEDURE-RELATED SAES WAS 5.36% (9/168) AND 7.23% (12/166) IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, SHOWING THAT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.5078), WHEREAS THE DEVICE RELATED SAES INCIDENCE WAS 1.79% (3/168) AND 3.61% (6/166) IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, THEREBY SHOWING THAT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.3348). THE OVERALL MORTALITY DURING THE 30 DAYS FOLLOW-UP PERIOD WAS 1.19% (2/168) AND 1.81% (3/166) IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, AND NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE 2 GROUPS (P ¼ 0.6837). IT WAS ALSO OBSERVED THAT MORTALITY WAS PROPORTIONAL TO THE PROCEDURE USED IN 1.19% (2/168) AND 1.20% (2/166) OF PATIENTS IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, HENCE SHOWING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 1.0000), WHEREAS THE DEVICE MORTALITY WAS 0.60% AND 1.20% IN THE TEST AND CONTROL GROUPS, RESPECTIVELY, SHOWING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P ¼ 0.6216) AND, THUS, AN ABSENCE OF MORTALITY DURING THE 6 MONTHS OR 12 MONTHS FOLLOW-UP PERIOD. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. 12 PROCEDURE RELATED SAES 2. 6 DEVICE-RELATED SAES 3. 16 NEUROLOGICAL COMPLICATIONS 2 SYMPTOMATIC INTRACRANIAL HEMORRHAGE 1 ANEURYSM RUPTURE OR REBLEEDING 10 SYMPTOMATIC CEREBRAL INFARCTION 3 OTHERS (HYDROCEPHALUS) 4. 3 DEATHS 2 PROCEDURE-RELATED DEATH 2 DEVICE-RELATED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048081 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-AXIUM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention