BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 20005429 · Received August 20, 2024

    Report

    Report Number
    2029214-2024-01448
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 19, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: WU, Q., YAO, J., QI, J., BI, Y., CHEN, A., YANG, Z., AI, C., CHEN, L., ZHANG, B., XU, S., LI, Z., SHI, H., <(>&<)> WU, P.. MICROSURGICAL CLIPPING VERSUS ENDOVASCULAR THERAPY FOR TREATING PATIENTS WITH MIDDLE CEREBRAL ARTERY ANEURYSMS PRESENTING WITH NEUROLOGICAL ISCHEMIC SYMPTOMS. NEUROSURGICAL REVIEW 1 2024. DOI:10.1007/S10143-024-02559-X 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. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    WU Q, YAO J, QI J, ET AL. MICROSURGICAL CLIPPING VERSUS ENDOVASCULAR THERAPY FOR TREATING PATIENTS WITH MIDDLE CEREBRAL ARTERY ANEURYSMS PRESENTING WITH NEUROLOGICAL ISCHEMIC SYMPTOMS. NEUROSURGICAL REVIEW. 2024;47(1):318. DOI:10.1007/S10143-024-02559-X   LITERATURE WAS REVIEWED REGARDING THE STUDY AIMING TO COMPARE MICROSURGICAL CLIPPING VERSUS ENDOVASCULAR THERAPY FOR TREATING PATIENTS WITH MIDDLE CEREBRAL ARTERY ANEURYSMS PRESENTING WITH NEUROLOGICAL ISCHEMIC SYMPTOMS. IT INVESTIGATES THE INCIDENCE OF SERIOUS ADVERSE EVENTS (SAES) WITHIN 30 DAYS OF TREATMENT, ANY NEUROLOGICAL COMPLICATIONS RELATED TO THE TREATMENT DURING FOLLOW-UP, POSTPROCEDURAL TARGET VESSEL-RELATED STROKE, COMPLETE OCCLUSION RATES, AND THE OVERALL POSTPROCEDURAL COMPLICATION RATE. THE STUDY ALSO IDENTIFIES RISK FACTORS ASSOCIATED WITH SAES, SUCH AS AGE AND DIABETES MELLITUS, TO PROVIDE INSIGHTS INTO THE SAFETY AND EFFICACY OF THE TWO TREATMENT MODALITIES. THE TIME FRAME OF THIS STUDY WAS JANUARY 2014 TO JULY 2022. A TOTAL OF 130 PATIENTS HARBORING 142 MCA ANEURYSMS WERE INCLUDED IN THIS STUDY, OF WHICH 45 PATIENTS (47 ANEURYSMS) WERE TREATED WITH ENDOVASCULAR THERAPY (ENDOVASCULAR GROUP) AND 85 PATIENTS (95 ANEURYSMS) WITH MICROSURGICAL CLIPPING (CLIPPING GROUP). THE COHORT COMPRISED 74 (56.9%) MEN, AND THE MEAN AGE WAS 60.8 YEARS. MULTIPLE MANUFACTURER'S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPEL INE EMBOLIZATION DEVICE AND SOLITAIRE STENTS. OF THE 47 ANEURYSMS IN THE ENDOVASCULAR GROUP, 34 (72.3%) WERE TREATED WITH STENT-ASSISTED COILING (SAC), 12 (25.5%) WITH SIMPLE COILING, AND 1 (2.1%) WITH FLOW DIVERSION. OF THE 34 ANEURYSMS TREATED WITH SAC, NEUROFORM STENT WAS USED IN 7 (20.6%), ENTERPRISE STENT IN 17 (50.0%), LVIS STENT IN 5 (14.7%), SOLITAIRE STENT IN 2 (5.9%), LVIS PLUS ENTER PRISE OVERLAPPING STENT IN 1 (2.9%), AND ¿Y¿ STENT (ENTERPRISE × 2) IN 2 (5.9%) ANEURYSMS AMONG PATIENT ADVERSE EVENTS INCLUDED: -THE INCIDENCE OF SERIOUS ADVERSE EVENTS (SAES) WITHIN 30 DAYS OF TREATMENT WAS SIGNIFICANTLY HIGHER IN PATIENTS TREATED WITH MICROS URGICAL CLIPPING [CLIPPING: 23.5% (20/85) VS ENDOVASCULAR: 8.9% (4/45)]. SAES FOR THE ENDOVASCULAR GROUP INCLUDED 4 CASES OF ISCHEMIC STROKE, 2 ACUTE IN-STENT THROMBOSIS AND 2 WITHOUT IN-STENT STENOSIS/THROMBOSIS. OLDER AGE AND DIABETES MELLITUS WERE IDENTIFIED AS FACTORS THAT COULD INCREASE THE RISK OF POSTPROCEDURAL SAES. -THE INCIDENCE OF ANY NEUROLOGICAL COMPLICATIONS RELATED TO THE TREATMENT WAS SIGNIFICANTLY HIGHER IN THE CLIPPING GROUP; (28/85) IN THE CLIPPING GROUP VS 15.6% (7/45) IN THE ENDOVASCULAR GROUP -NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN THE CLIPPING AND ENDOVASCULAR GROUPS FOR THE RISKS OF POSTPROCEDURAL TARGET VESSEL¿R ELATED STROKE [23.5% (20/85) VS 15.6% (7/45)], DISABLING STROKE OR DEATH [21.2% (18/85) VS. 11.1% (5/45)], OR MORTALITY RATES [4.7% (4/85) VS 4.4% (2/45)]. THE SPECIFIC CAUSES OF DEATH REMAIN UNDISCLOSED IN THE CONTEXT PROVIDED. -THE COMPLETE OCCLUSION RATE WAS 90.4% IN THE CLIPPING GROUP AND 80.0% (24/30) IN THE ENDOVASCULAR GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373377 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Disability