MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED2-425-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Bronchopneumonia (2437)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report of a post-procedure adverse event (ae) of pneumonia that is procedure related.It was reported that on 2024 (b)(6) new hospitalization occurred for the patient that encountered the ae of pneumonia until 2024 (b)(6) with the outcome status of recovered/resolved.The ae resulted in treatment given zyvox and zosyn.The ae did was not treated with a blood transfusion, percutaneous intervention, or surgical procedure.No diagnostic tests or procedures were performed.The relative time from the index procedure was post-procedure.The ae was not related to the disease under study.It did not result in new or worsening of existing neurological deficits.The ae did not result from a device deficiency.The patient came in with right sided chest pain; troponins negative, increased white blood cell count and febrile.The patient was admitted with concern for pneumonia.Infectious disease following on zyvox and zosyn for suspected hap (hospital-acquired pneumonia).The blood cultures were negative.The site seriousness assessment concluded that there was no congenital anomaly, death, disability, life threatening, medical intervention present, however, hospitalization was.The site related assessment concluded that there was no relation to apt medication, retreatment procedure, rist catheter, study device, or the study index procedure.The sponsor assessment (oc muo) concluded that mdt possible to index procedure, not related to apt or study device.(b)(6) 2026 per site query response that chest pain was a symptom secondary to the report ae.The patient was undergoing surgery for treatment of a saccular aneurysm located in the right internal carotid artery c7 sidewall with a max diameter of 3mm and a 3mm neck diameter.The aneurysm dome height was 6mm and width was 3mm.The parent artery diameter distal and proximal to the aneurysm was 4mm.Vessel tortuosity is not collected for this study.There was no stasis post-implant.There was complete neck coverage at the end of the procedure.Raymond and roy was recorded as class 1.Only 1 aneurysm was treated with the study device.Access was made via the radial right.The study device was successfully implanted with wall apposition achieved.No side branches were covered by the pipeline.There was no device twisting or flattening.Ancillary devices include a rist radial access, navien, phenom 27.
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 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 ; +1(763)526-5677
• MDR Report Key: 50477567
• Report Number: 2029214-2026-01691
• Device Sequence Number: 21383418
• Product Code: OUT
• UDI-Device Identifier: 00763000284428
• UDI-Public: (01)00763000284428(17)260411(10)B547381
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 04/11/2026
• Device Model Number: PED2-425-14
• Device Catalogue Number: PED2-425-14
• Device Lot Number: B547381
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 04/12/2023
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 147 LB