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

Model Number	PED2-475-25
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
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 of a pipeline device that failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the posterior cerebral artery with a max diameter of 4.3mm and a 3.8mm neck diameter.The landing zone (artery size) 3.6mm distal and 3.8mm proximal.It was noted the patient's vessel tortuosity was severe.The angiographic result post procedure was, "the aneurysm issue was perfectly resolved postoperatively, and the dense mesh flow-diverting stent was well opposed to the vessel wall." it was reported that the device was advanced through a normal access route to the lesion site, and the dense mesh flow-diverting stent was then deployed.During deployment, the proximal end of the dense mesh flow-diverting stent was unable to fully deployed.Despite manipulation techniques such as combined pushing and pulling, the tip end of the stent could not be fully opened.It was noted that there was failure to open in the proximal section of the device.The pipeline was not positioned in a bend.The pipeline was not stuck in the capture coil.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than 2 times.No additional steps or other devices were required to open the pipeline.The pipeline was resheathed and removed with the microcatheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The pipeline was not used for any indication that is not approved (off-label).Ancillary devices include a terumo vascular sheath kit: rs*a80k10sq, boston scientific, m001198260.Support catheter, tongqiao-tdgc070-06-115 , phenom27 - fg150150-0615-1s, and a yingtai 0.014-200cm.

• 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: 24765731
• Report Number: 2029214-2026-00594
• Device Sequence Number: 9153601
• Product Code: OUT
• UDI-Device Identifier: 00763000449483
• UDI-Public: (01)00763000449483(17)281019(10)D074371
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: D074371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/22/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/01/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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
• Patient Age: 66 YR
• Patient Sex: Female