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

Model Number	PED2-450-25
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report of a pipeline device that failed to open and encountered resistance with a marksman microcatheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the right side of the c6 segment with a max diameter of 5mm and a 4.7mm neck diameter.The landing zone (artery size) was 4.3mm distal and 4.6mm proximal.The access vessel was the femoral artery with a diameter of 7.6mm.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered with an unknown platelet reactivity units (pru) level.The angiographic result post procedure was an, "aneurysm contrast agent retention." it was reported that the access system was successfully established, extending the intermediate catheter to the distal c3 segment.Guided by a micro-guidewire, a markman stent microcatheter was advanced to the right m2 segment.A 4.5*25 flow-diverting stent was then advanced through markman and slowly deployed within the internal carotid c7 segment; however, the surgeon observed suboptimal opening of the stent's tip.Despite attempting to adjust the position to continue deployment, the tip of the stent was still found to exhibit incomplete visualization and wall apposition.Consequently, the entire assembly was withdrawn, revealing an abnormality in the braiding wire at the stent's tip.Prioritizing patient safety, the surgeon switched to a phenom 27 stent microcatheter and a 4.5*20 stent, which was then slowly deployed within the c6 segment along the intermediate catheter.The stent opened satisfactorily and was successfully deployed, bringing the procedure to a close.The procedure was completed successfully.It was noted that there was catheter resistance in the distal section of the device.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 an indication that is not approved (off-label).The catheter was flushed as indicated in the ifu.
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 ; 7635265677
• MDR Report Key: 24789592
• Report Number: 2029214-2026-00605
• Device Sequence Number: 18344415
• Product Code: OUT
• UDI-Device Identifier: 00763000449391
• UDI-Public: (01)00763000449391(17)280818(10)D058925
• 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): 06/25/2026

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: PED2-450-25
• Device Catalogue Number: PED2-450-25
• Device Lot Number: D058925
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 06/06/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 50 KG