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

Model Number	PED2-425-25
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report of pipeline failure to open and a navien kink.The patient was undergoing flow-diverting mesh stent implantation surgery for treatment of a fusiform, unruptured, left clinoid segment aneurysm with a max diameter of 9 mm and a 4.9 mm neck diameter.The landing zone was 3.9 mm distally and 4.2 mm proximally.The access vessel was the femoral artery with a diameter of 20 mm.It was noted the patient's vessel tortuosity was severe.The angiographic result post procedure showed a clinoid segment aneurysm.It was reported that the patient was approached via the femoral artery, and the vessel was severely tortuous.The stent catheter was delivered into position, and the flow-diverting mesh pipeline stent was advanced to the straight segment.When deployment was performed, the distal end could not open.Repeated adjustments were unsuccessful.It was removed and then replaced.During delivery of the intermediate navien catheter, there was significant resistance at the tip end.It could not be positioned.After withdrawal, a kink was found at the tip end of the navien, and it was replaced.The kink was the distal end.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was not positioned in a bend and less than 50% had been deployed when it failed to open.The pipeline was resheathed more than to 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient.The catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with this event.Ancillary devices include a johnson & johnson sheath, a johnson & johnson guide catheter, a phenom microcatheter, and a styker 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.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: 50869251
• Report Number: 2029214-2026-01892
• Device Sequence Number: 10674005
• Product Code: OUT
• UDI-Device Identifier: 00763000284466
• UDI-Public: (01)00763000284466(17)280617(10)D046402
• 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
• Report Date (Section B): 09/23/2026

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: PED2-425-25
• Device Catalogue Number: PED2-425-25
• Device Lot Number: D046402
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 06/18/2025
• 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: Male
• Patient Weight: 141 LB