BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 21635468 · Received March 18, 2025

    Report

    Report Number
    2029214-2025-00697
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    October 23, 2024
    Report Date
    March 18, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE IS THE MEAN AGE FROM ALL PATIENTS INCLUDED IN THE STUDY GROUP. A3. REPORTED PATIENT SEX IS REPRESENTATIVE OF THE SEX OF THE MAJORITY (9/12) OF PATIENTS IN THE STUDY GROUP. B3. REPORTED EVENT DATE IS THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    SWEID, A., CHAHINE, A., HAGE, S., MORSI, R. Z., THIND, S., KARAR, L., BASKARAN, A., CARRIÓN-PENAGOS, J., DESAI, H., KOTHARI, S. A., RANA, R., VERHAGEN METMAN, O., ZAKARIA, J., SIEGLER, J. E., AWAD, I., HURLEY, M. C., PRABHAKARAN, S., POLSTER, S., & KASS-HOUT, T. (2024). FOURTH-GENERATION PIPELINE¿ VANTAGE FLOW DIVERSION: FIRST REPORTED US EXPERIENCE OF SAFETY AND FEASIBILITY. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES, 15910199241301120. H TTPS://DOI.ORG/10.1177/15910199241301119. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A SINGLE CENTER RETROSPECTIVE STUDY WHICH ASSESS THE USE OF THE PIPELINE VANTAGE EMBOLIZATION DEVICE FOR TREATING INTRACRANIAL ANEURYSMS IN 12 PATIENTS. SEVEN CASES WERE TREATED WITH ADJUNCT EMBOLIZATION DEVICE OTHER THAN A FLOW DIVERSION AND MULTIPLE FLOW DIVERTERS WERE USED IN FOUR CASES (TWO STENTS WERE IMPLANTED IN THREE CASES, AND THREE STENTS WERE IMPLANTED IN ONE CASE). PHENOM PLUS INTERMEDIATE CATHETERS AND EITHER PHENOM 21 OR PHENOM 27 MICROCATHETERS WERE USED INTRA -OPERATIVELY. THERE WAS A 100% SUCCESS IN DEPLOYMENT WITH GOOD WALL APPOSITION OBSERVED AND NO ANGIOPLASTY WAS REQUIRED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THERE WAS ONE POST-OPERATIVE COMPLICATION WHICH OCCURRED IN CASE IN WHICH A DISSECTING RUPTURED POSTERIOR INTERNAL CAROTID ARTERY ANEURYSM THAT WAS TREATED WITH TWO STENTS AND AN INTRASACCULAR DEVICE. ALTHOUGH THE PATIENT WAS ON A CANGRELOR DRIP, THERE WAS COMPLETE VESSEL/STENT THROMBOSIS. THOUGH AT BASELINE 11/12 PATIENTS HAD MRS 0-2 AND ONE PATIENT HAD MRS, IT WAS NOTED THAT AT DISCHARGE, MRS WAS 3-5 IN TWO CASES AND ONE PATIENT CONTINUED TO HAVE MRS 3 WITHIN 2 WEEK FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372538 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-PED3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other| S