BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 19351795 · Received May 20, 2024

    Report

    Report Number
    2029214-2024-00943
    Event Type
    Death
    Date Received
    May 20, 2024
    Date of Event
    January 1, 2012
    Report Date
    May 20, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: BENALIA V, CORTEZ G, MOUNAYER C, SAATCI I, CEKIRGE H, KOCER N, ISLAK C, DABUS G, BRINJIKJI W, BALTACIOGLU F, PEREIRA V, NISHI H, SIDDIQUI A, MONTEIRO A, LOPES D, AGHAEBRAHIM A, SAUVAGEAU, HANEL R. SAFETY AND EFFICACY OF FLOW DIVERTERS FOR TREATMENT OF UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSMS: RETROSPECTIVE MULTICENTER STUDY. J NEUROINTERVENT SURG 15:1181¿1186 2023. 10.1136/JNIS-2023-020673 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

    LITERATURE WAS REVIEWED REGARDING OUTCOMES OF FLOW DIVERTERS IN ACOMM ANEURYSM TREATMENT. A TOTAL OF 144 PATIENTS HARBORING 147 ACOMM ANEURYSMS WERE TREATED BETWEEN JANUARY 2012 AND DECEMBER 2021. SEVENTY-FOUR WERE WOMEN (51.4%) AND MEDIAN AGE WAS 60 (IQR 50¿67) YEARS. ALL WERE UNRUPTURED ACOMM ANEURYSMS. HALF OF THE COHORT HAD SIMILAR ANTERIOR CEREBRAL ARTERY SIZES (51.4%). THE MOST COMMON MORPHOLOGY WAS SACCULAR (94.6%), WITH A BRANCH INVOLVEMENT IN 32.7% OF CASES. MEDIAN VESSEL DIAMETER WAS 2.4MM, AND THE PIPELINE FLEX WAS THE MOST PREVALENT DEVICE (32.7%). MEDIAN FOLLOW-UP TIME WAS 17 MONTHS, WITH COMPLETE OCCLUSION IN 86.4% AT THE LAST FOLLOW-UP. FUNCTIONAL INDEPENDENCE (MODIFIED RANKIN SCALE SCORE 0¿2) WAS REPORTED IN 95.1%. INTRAPROCEDURAL COMPLICATIONS OCCURRED IN 5.6%, AND POSTOPERATIVE COMPLICATIONS WERE NOTED IN 9.7% OF CASES. COMBINED MAJOR COMPLICATION AND MORTALITY RATE WAS 2.1%. DEVICE ISSUES INCLUDED DEVICE MIGRATION AND DEVICE SHORTENING.   1. THROMBOSIS 2. VASOSPASM 3. NON-FLOW LIMITING DISSECTION 4. BRANCH OCCLUSION 5. DISTAL THROMBOEMBOLIC 6. DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855890 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death