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

Model Number	PED2-500-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
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 in the distal section of the device.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the left c6 segment.It was noted the patient's vessel tortuosity was minimal.The landing zone (artery size) was 4.4mm distal and 4.9mm proximal.Dapt (dual antiplatelet treatment) was administered which had a platelet reactivity units (pru) of 100.The angiographic result post procedure was, "blood flow in the tumor-feeding artery and distal vessels was patent." it was reported that a ped2 500 16 flow diverter was selected for implantation.Vascular access was established using a 6f delivery catheter combined with a 5f 115 cm navien catheter.The phenom 27 stent catheter was advanced over a guidewire to the m1 segment.After the protective sheath was positioned flush against the hub of the phenom 27, the stent was advanced to the m1 segment.After the stent catheter came out, an attempt was made to deploy the distal tip end of the stent.The distal tip end opened approximately 5 mm but failed to fully open.Further deployment was attempted without successful opening.The stent was then retracted and repositioned within the internal carotid artery; repeated attempts were unsuccessful, and the system was subsequently withdrawn.The pipeline was not positioned in a bend.It was not specified if the pipeline was stuck in the capture coil.More than 50% of the pipeline had been deployed when it failed to open.The pipeline resheathed less than or equal to 2 times.No additional steps or other devices required to open the pipeline.The pipeline was removed from patient.It was indicated that all devices were prepared as per the in structions 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).

• 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: 24858034
• Report Number: 2029214-2026-00653
• Device Sequence Number: 10517383
• Product Code: OUT
• UDI-Device Identifier: 00763000284701
• UDI-Public: (01)00763000284701(17)280814(10)D058302
• 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): 06/22/2026

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: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: D058302
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/27/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/12/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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: 56 YR
• Patient Sex: Female