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

Model Number	PED2-475-14
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the patient underwent 1 year follow-up digital subtraction angiography (dsa) on (b)(6) 2025.There was 76%-95% parent artery stenosis.Per the adjudication committee, there was evidence of significant parent artery stenosis > 50.Branches had a degree of stenosis.The posterior communicating (pcom) artery was angiographically occluded.Ophthalmic was 26%-50%.Additional information was received reporting that dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level 113%.The patient underwent surgery for treatment of an unruptured, saccular, right hemisphere, c6 sidewall aneurysm with a max diameter of 8.0mm and a neck diameter of 3.7mm.The landing zone was 4.0mm distally and 4.5mm proximally.Patient medical history includes: previous cigarette smoker, adhd, sleep apnea, depression, anxiety, borderline personality disorder.Patient status is alive with no 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.
Additional Manufacturer Narrative
B5 updated with additional information received.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 the ophthalmic artery,anterior aneurysm was treated with pipeline model: ped2-475-14, lot#:b321852 and the right ophthalmic branch aneurysm was treated with pipeline model: ped2-475-12 lot#: b337129.There were no associated patient symptoms and no additional intervention were reported.The cause of the stenosis was not determined.The affected vessel was treated with the ped2-475-14, lot: b321852.There was no complaint reported regarding the pipeline ped2-475-12, lot: b337129.
Additional Manufacturer Narrative
H3: additional information provided that (b)(4) is related and merged into (b)(4).All information submitted under 2029214-2025-01228 is related to all information under 2029214-2024-00070.Any further updates will come through 2029214-2024-0 0070.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 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: 22059498
• Report Number: 2029214-2025-01228
• Device Sequence Number: 18260027
• Product Code: OUT
• UDI-Device Identifier: 00763000284602
• UDI-Public: (01)00763000284602(17)250111(10)B321852
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 02/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2025
• Device Model Number: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: B321852
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 01/30/2026
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/11/2025; 02/20/2026
• Date Device Manufactured: 01/12/2022
• 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: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 75 KG