BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM

    MDR report key: 18181512 · Received November 21, 2023

    Report

    Report Number
    2029214-2023-02256
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    February 21, 2022
    Report Date
    November 21, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    TAKESHI HARA, TOSHINORI MATSUSHIGE, MICHITSURA YOSHIYAMA, YUKISHIGE HASHIMOTO, SHOHEI KOBAYASHI, AND SHIGEYUKI SAKAMOTO; JOURNAL OF NEUROSURGERY; 2023; 138:147¿153; ASSOCIATION OF CIRCUMFERENTIAL ANEURYSM WALL ENHANCEMENT WITH RECURRENCE AFTER COILING OF UNRUPTURED INTRACRANIAL ANEURYSMS: A PRELIMINARY VESSEL WALL IMAGING STUDY; THEJNS.ORG/DOI/ABS/10.3171/2022.4.JNS224 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS POTENTIALLY TREATED WITH AXIUM COILS HAVING COMPLICATIONS. THE PURPOSE OF THE ARTICLE WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN ANEURYSM WALL ENHANCEMENT (AWE) PATTERNS ON VESSEL WALL IMAGING (VWI) BEFORE TREATMENT AND RECURRENCE AFTER COILING. BETWEEN APRIL 2017 AND JUNE 2021, 222 CONSECUTIVE PATIENTS HARBORING 298 SACCULAR UNRUPTURED INTRACRANIAL ANEURYSMS (UIAS) WERE PROSPECTIVELY EVALUATED WITH VWI. SEVENTY-TWO UIAS WERE TREATED WITH COIL EMBOLIZATION AND 73 WITH MICROSURGICAL CLIPPING, WHEREAS 153 WERE MONITORED AS REQUESTED BY PATIENTS. SIXTY-SEVEN PATIENTS WITH 67 SACCULAR UIAS WERE INCLUDED IN THE PRESENT STUDY. THE PATIENTS INCLUDED 20 MALES AND 47 FEMALES (MEAN AGE ± SD 67.6 ± 12.2 YEARS). SIXTY ANEURYSMS WERE LOCATED IN THE ANTERIOR CIRCULATION AND 7 IN THE POSTERIOR CIRCULATION. PROCEDURE: ENDOVASCULAR COIL EMBOLIZATION WAS PERFORMED WITH THE PATIENT UNDER GENERAL ANESTHESIA. BARE PLATINUM COILS (AXIUM PRIME, TARGET, AND ED COILS) AND BIOACTIVE COILS (HYDROCOIL) WERE USED. BALLOON-REMODELING OR STENT-ASSISTED TECHNIQUES WERE SELECTED ON THE BASIS OF ANEURYSM NECK MORPHOLOGY. AN LVIS (MICROVENTION TERUMO) OR NEUROFORM (STRYKER) STENT WAS USED FOR STENT-ASSISTED COILING. VER WAS CALCULATED AS THE RATIO OF PACKED COIL VOLUME TO ANEURYSM VOLUME. IMMEDIATE EMBOLIZATION STATUS WAS QUALITATIVELY CLASSIFIED AS CLASS I TO IIIB ACCORDING TO MODIFIED RAYMOND-ROY OCCLUSION CLASSIFICATION (MRRC). RESULTS: AWE WAS CLASSIFIED INTO THE FOLLOWING 3 PATTERNS, AS PREVIOUSLY REPORTED: 1) CIRCUMFERENTIAL AWE (CAWE), I.E., WALL ENHANCEMENT IN THE BROAD PART OF THE ANEURYSM WALL; 2) FOCAL AWE (FAWE), I.E., PARTIAL ENHANCEMENT IN THE ANEURYSM WALL; AND 3) NEGATIVE AWE (NAWE), I.E., NO ENHANCEMENT IN THE ANEURYSM WALL. INTERRATER AGREEMENT REGARDING THE EVALUATIONS OF THE AWE PATTERNS WAS GOOD. AFTER THE FINAL CONSENSUS READING, THE AWE PATTERNS ON VWI BEFORE TREATMENT WERE CLASSIFIED AS FOLLOWS: 10 CAWE (14.9%), 20 FAWE (29.9%), AND 37 NAWE (55.2%). FOLLOW-UP MRA DETECTED SIGNAL CHANGES AROUND THE ANEURYSMAL NECK IN 18 OF 67 CASES AT THE 6-MONTH FOLLOW-UP. SIX ANEURYSMS EXHIBITED REGROWTH, WHEREAS 12 SHOWED MAJOR COIL COMPACTION. ONE PATIENT WAS RETREATED WITH MICROSURGICAL CLIPPING AND 1 WITH COIL EMBOLIZATION. THE OTHER 16 PATIENTS WERE CAREFULLY MONITORED WITH MRI AT THE OUTPATIENT CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796904 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-AXIUM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention