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

Model Number	PED2-450-20
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the marksman catheter and phenom catheter encountered resistance with a stent and were both found damaged.The patient was undergoing aneurysm treatment.The accessed vessel was the femoral artery with a diameter of 10 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that the blood vessels were tortuous, and when the marksman was raised, a lot of resistance was felt, making it difficult to deliver the stent forward.After torque control, continued to deliver it upward.It was felt that the marksman was flaccid and could not be pushed forward.When withdrawing it, it was found that the front end of the catheter was damaged.After changing to p27, it was smoothly in place.The stent was difficult to open when deployed.After retrieving it, it was put in place again to deploy the stent.The stent fell off twice due to insufficient anchoring.After repeated retrieving twice, obviously felt that the support force of the catheter was insufficient.It was suspected that the front end of the catheter was damaged, so it was withdrawn and the front end was found to be kinked.The problem was solved after replacing it with a new p27.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Additional information received reported that the cause might have been related to the tortuosity of the blood vessel.
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: 21758638
• Report Number: 2029214-2025-00868
• Device Sequence Number: 8721295
• Product Code: OUT
• UDI-Device Identifier: 00763000284541
• UDI-Public: 00763000284541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/02/2025

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: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B741042
• 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: 03/09/2025
• Initial Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 06/04/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 50 KG