BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 25021979 · Received April 28, 2026

    Report

    Report Number
    2029214-2026-00764
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    March 13, 2022
    Report Date
    April 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536030725
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED3 PIPELINE HAD AMAUROSIS, TRANSIENT BLURRING. THE PATIENT WAS BEING TREATED FOR A SACCULAR, SIDEWALL ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY (ACA). RIGHT HEMISPHERE. MAXIMUM ANEURYSM DIAMETER: 5MM. ANEURYSM DOME HEIGHT: 4MM. ANEURYSM DOME WIDTH: 5MM. ANEURYSM NECK SIZE: 3MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.4MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 2.2MM. POST IMPLANT THERE WAS NO STASIS. THERE WAS COMPLETE COVERAGE AT THE END OF THE PROCEDURE. RAYMOND AND ROY OCCLUSION CLASS 3 AT THE END OF THE PROCEDURE. DIAGNOSTICS FOUND MICRO HEMORRHAGES OF RETINA. NO ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE ISSUE RESOLVED ON (B)(6) 2022. THE EVENT WAS PROBABLY RELATED TO ANTIPLATELET MEDICATION. IT IS POSSIBLY RELATED TO STUDY DEVICE AND PROBABLE RELATION TO PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2022. THE LEFT A1 AND RIGHT POSTERIOR ARTERY SIDE BRANCHES WERE COVERED BY THE PIPELINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ALSO SUFFERED FROM HEADACHES COINCIDING WITH THE AMAUROSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CEC ADJ ON (B)(6) 2022: CAUSAL TO INDEX PROCEDURE, NOT RELATED TO DEVICE VANTAGE OR DAPT. ADDITIONAL INFORMATION RECEIVED REPORTED CEC ADJ ON (B)(6) 2022: CAUSAL TO INDEX PROCEDURE, NOT RELATED TO DEVICE VANTAGE OR DAPT; CEC ALSO NOTED MULTIPLE SMALL LESIONS IN RT HEMISPHERE IPSILATERAL TREATED ANEURYSM AND A LESION LEFT TEMPORAL POLE. PER SITE POST-PROCEDURE FEVER, INVESTIGATOR FEVER IS NOT DUE TO PROCEDURE TREATED WITH PARACETAMOL NO CAUSE FOUND PROBABLY FLU SYNDROME; RE: LESIONS ON IMAGING, PER PI ASSOC W/TICAGRELOR COMPLIANCE. ADDITIONAL INFORMATION RECEIVED REPORTED MULTIPLE SWI LESION AT MRI. IT WAS ASYMPTOMATIC. NO ACTIONS WERE TAKEN. THE EVENT WAS POSSIBLY RELATED TO STUDY DEVICE, ANCILLARY DEVICES, STUDY PROCEDURE AND ANTIPLATELET MEDICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ADVERSE EVENT TERM WAS UPDATE TO CEREBRAL VASCULAR LESIONS WITH NO PRIMARY DIAGNOSIS IDENTIFIED. THE LESIONS DID NOT RESULT IN HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED. THE SIDE BRANCHES WERE THE RIGHT A1 AND THE RIGHT POSTERIOR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349063 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-021-350-20 B222985 00847536030725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization