MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED3-027-400-16
Medical Device Problem Codes	Collapse (1099); Structural Problem (2506); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Codes	Stenosis (2263); Ischemia Stroke (4418)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received a report of a physician stating a device recall to patient.Patient stated this has been previously recorded, and that physician stated to patient medtronic would be contacting her.Physician stated to patient of having a hard time deploying the device.Patient stated she ended up having a stroke after the procedure.Patient had another angiogram in august and patient stated device has closed some.Patient stated having follow up appointment scheduled with physician but they have not gotten back to her for questions she has.Found out about issue (b)(6) 2025, re-imaged in (b)(6) 2025.Patient has follow up appointments scheduled.Resolution was answered question and provided education/documentation.
Event or Problem Description
Additional information was received that the patient (pt) noted they had some issues with a brain stent, it didn¿t open.The pt reported they "thought they were going to die but they are still here".Pt noted they were informed by their hcp that they had a hard time during the surgery and the device would not stay open and the hcp almost gave up but gave it one last attempt and made it work.Pt noted the device stayed open, they had an angiogram later on, but the device had closed up some in their brain.Pt is not sure on what their health outcome will be but noted they are having a meeting with the hcp wednesday (b)(6) 2026.Pt noted they aren¿t sure on why the doctor requested to meet them, but they hope it is for good news.
Additional Manufacturer Narrative
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.

• Brand Name: PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23498036
• Report Number: 2029214-2025-02350
• Device Sequence Number: 18368766
• Product Code: OUT
• UDI-Device Identifier: 00847536036703
• UDI-Public: (01)00847536036703(17)270422(10)B721778
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED3-027-400-16
• Device Catalogue Number: PED3-027-400-16
• Device Lot Number: B721778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1245-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown