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	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	01/29/2025
Type of Reportable Event	Death
Event or Problem Description
Medtronic received a report that during post-operation a pipeline device was found to have thrombosis in the device.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the para-ophthalmic segment.It was noted the patient's vessel tortuosity was moderate.There was no patient symptoms or complications associated with the flow diversion implantation event.Dual antiplatelet therapy (dapt) was administered.The angiographic result post-procedure was equivalent to baseline.The patient status at the time of the report is deceased as of (b)(6) 2026.It was reported that patient was found unresponsive at home.Subsequent imaging revealed thrombosis of the pipeline device, resulting in a major ischemic stroke.The patient later died.The pipeline was not used for an indication that is not approved (off-label).It was indicated that all devices were prepared as per the instructions for use (ifu).It was noted that there was no alleged product issue.Ancillary devices include a non-medtronic (neuron max) guide catheter, a phenom plus guide catheter, phenom 27 microcatheter, and a non-medtronic (synchro 2) guidewire.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction for h6.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: 24247891
• Report Number: 2029214-2026-00216
• Device Sequence Number: 9593488
• Product Code: OUT
• UDI-Device Identifier: 00763000284428
• UDI-Public: (01)00763000284428(17)280520(10)D040613
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Model Number: PED2-425-14
• Device Catalogue Number: PED2-425-14
• Device Lot Number: D040613
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 05/21/2025
• 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: Death
• Patient Age: 55 YR
• Patient Sex: Female