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

Model Number	PED2-425-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Nervous System Injury (2689)
Date of Event	10/08/2025
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 that at 1 year digital subtraction angiography (dsa) imaging follow-up, the site reported a raymond and roy, occlusion score of class 2.No parent artery stenosis, complete neck coverage, and complete wall apposition.Class 2 was also reported at the 180-day dsa imaging follow up.Previous mrs reported was 0 at the 180 day visit, however at the 1 year visit the site reported a mrs of 2.No known patient symptoms or complications were associatedwith this event.The patient had undergone dense mesh flow diversion implant on (b)(6) 2025 for treatment of a right hemisphere, c7, bifurcation branch aneurysm.Follow-up 1 year dsa imaging reported a previously ruptured, saccular, right hemisphere, c7, bifurcation branch aneurysm with a max diameter of 6.8 mm and a 6.3 mm neck diameter.The landing zone arterial diameter was 4.3 mm distally and 3.7 mm proximally.Dual antiplatelet treatment (dapt) was administered; however, platelet reactivity testing was not performed.
Additional Manufacturer Narrative
Based on additional information received, there was no reported device malfunction and the there was no serious patient injury.Mdr decision corrected to not reportable.No additional supplemental reporting is required for this event unless additional information received indicates a reportable event.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
Additional information received reported site noted previous entry for mrs2 at 1-year follow-up was incorrect.The patient's mrs at 1-year follow-up has been corrected to 0.Regarding observed r occlusion class 2: the patient had no associated symptoms.No actions taken or planned for observed incomplete occlusion.The event did not result in hospitalization.Based on additional information received, there was no reported device malfunction and the there was no serious patient injury.Mdr decision corrected to not reportable.No additional supplemental reporting is required for this event unless additional information received indicates a reportable event.

• Brand Name: PIPELINE FLEX W/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: 23496975
• Report Number: 2029214-2025-02345
• Device Sequence Number: 13010040
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: (01)00763000284459(17)241212(10)B311688
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2024
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: B311688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 12/13/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG