BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 24251867 · Received February 3, 2026

    Report

    Report Number
    2029214-2026-00219
    Event Type
    Death
    Date Received
    February 3, 2026
    Date of Event
    January 3, 2026
    Report Date
    May 7, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536036529
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED. H6 CODES UPDATED. BASED ON NEW INFORMATION. REMOVED E0602, F24. 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.

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANEURYSM WAS LEFT SUPERIOR HYPOPHYSEAL, 12 MM. THE PATIENT HAD A HISTORY OF HYPERTENSION (HTN) AND HYPOTHYROIDISM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS 14. IT WAS REPORTED THAT IT WAS UNKNOWN IF THERE WAS A DEVICE ISSUE THAT WAS ENCOUNTERED, HOWEVER, THE SECOND PED3 IMPLANT WAS NEEDED FOR APPROPRIATE NECK COVERAGE. THE PATIENT EXPERIENCED AN ANEURYSMAL RUPTURE APPROXIMATELY 12H POST PIPELINE DEPLOYMENT AND PASSED AWAY IN A HOSPITAL. NO AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THE CAUSE OF DEATH WAS THOUGHT TO BE RELATED TO THE MEDTRONIC DEVICE OR THERAPY. THERE WERE NO ADDITIONAL MEDICAL EVENTS/PROCEDURES LEADING UP TO THE PATIENT'S DEATH (RECENT REFILL, DOSE CHANGE, HOSPITALIZATION, OTHER TREATMENTS); THERE WAS NO ADMITTING DIAGNOSIS.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT A PATIENT HAD TWO PIPELINE VANTAGE WITH SHIELD TECHNOLOGY STENTS IMPLANTED ON (B)(6) 2026, PED3-021-350-16  FOLLOWED BY PED3-021-350-14. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED IT LOOKED ACCEPTABLE, HOWEVER, THE PATIENT DIED ON (B)(6) 2026, THE DAY FOLLOWING THE PROCEDURE. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF A RUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442748 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-021-350-16 B770633 00847536036529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death