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

Model Number	PED2-475-20
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report of pipeline device that failed to open and was found damaged.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm located in the c6 segment of the internal carotid artery.The aneurysm dimensions reported was a max diameter of 4.9mm and a 3.9mm neck diameter.The landing zone (artery size) was 4.3mm distal and 4.8mm proximal.It was noted the patient's vessel tortuosity was moderate.The angiographic post-procedure result was the vessel condition was good, with no rupture and no significant stenosis.It was reported that based on the vessel diameter, the operator selected a 4.75-20ped.After the 90 cm cerebase da and 115 cm 5f navien with the phenom 27 microcatheter were positioned appropriately, the ped was prepared according to the instructions for use and fully hydrated, then advanced to the straight segment of the middle cerebral artery.Retraction of the phenom 27 microcatheter was initiated to deploy the ped.During deployment, it was noted that the distal tip end of the ped did not open.Further deployment with repeated push¿pull maneuvers was attempted; however, the distal tip end remained unopened.The ped was then completely retrieved into the phenom 27 microcatheter and repositioned to the proximal posterior communicating artery for in situ deployment.Despite pushing the delivery wire, the distal tip end of the ped still failed to open.After removal from the body, the distal tip end of the ped was found to be frayed.The device was replaced.The pipeline was not used for an indication that is not approved (off-label).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.Ancillary devices include a cerebase da 90 cm sheath, 5f navien 115cm guide catheter, phenom27 microcatheter, and a stryker synchro2 standard 0.014 in × 200 cm micro 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.
Event or Problem Description
Additional information received.The cause of the event was not determined.No causes or contributing factors for the failure to open and fraying were identified.The pipeline had not been placed in a vessel bend when it failed to open.
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: 24568323
• Report Number: 2029214-2026-00407
• Device Sequence Number: 20928840
• Product Code: OUT
• UDI-Device Identifier: 00763000449476
• UDI-Public: (01)00763000449476(17)280916(10)D065936
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: D065936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/21/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/07/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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: 58 YR
• Patient Sex: Male