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

Model Number	PED2-400-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Paresis (1998)
Date of Event	04/17/2025
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 a patient experienced hemiparesis in their right arm a week after they were implanted with a pipeline and 12x30mm axium frame coil.The pipeline had been deployed with no issues. the devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ophthalmic segment.The max diameter was 15x17mm, and the neck diameter was 5mm.The landing zone was 2.23mm distal and 3.67mm proximal.The patient's vessel tortuosity was moderate. dual antiplatelet treatment was administered.  ancillary devices include a cook 7f shuttle guide catheter, phenom 27 microcatheter, echelon 10 microcatheter, and synchro standard guidewire.Additional information received reported that the hemiparesis was caused by a parenchymal hemorrhage on the ipsilateral side.The physician does not know the cause of the hemorrhage.The patient condition was the same as was previously reported.

• 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: 21973311
• Report Number: 2029214-2025-01135
• Device Sequence Number: 7272613
• Product Code: OUT
• UDI-Device Identifier: 00763000284329
• UDI-Public: 00763000284329
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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 Model Number: PED2-400-12
• Device Catalogue Number: PED2-400-12
• Device Lot Number: B808411
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 10/24/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 74 KG