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

Model Number	PED2-475-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two pipeline embolization stents failed to open at the distal section.The patient was undergoing treatment of a saccular, unruptured right ica- cavernous segment aneurysm with unknown max diameter and a 3.6mm neck diameter.It was noted the patient's vessel tortuosity was normal.The landing zone was 3.75mm distally and 4.75mm proximally.Dual antiplatelet treatment (dapt) was administered.The pru level was unknown.It was reported that two pipeline were prepared per ifu.The physician advanced the device distal to the phenom 27 catheter, positioning it in the straight segment of the m1.Once the tip coil of the pipeline was aligned with the catheter, the physician began deployment, unsheathing approximately one-third of the braid.With little success in opening the distal braid, the physician proceeded to flip the ptfe sleeves.Additional maneuvers were attempted, including deploying more braid, wagging, resheathing, and pushing the delivery wire, but the braid remained constricted.As the distal segment began to trumpet, the physician elected to remove the device, and replaced with same type of device.However, the replacement device also failed, and the procedure could not be completed successfully.The pipelines were not positioned in a bend and was not stuck in the capture coil.More than 50% of the pipeline was deployed when it failed to open and was resheathed more than two times.There were no additional steps or other devices required to open the pipelines.The pipelines were resheathed and removed with the microcatheter from the patient.The pipelines were used for an indication that is approved (on-label).The angiographic result post procedure showed that the stent was fully deployed, well opposed, and patent.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a cook, scentia distal ica guidewire, medtronic phenom 27 microcatheter, armadillo 7fr guide catheter, terumo medical 7fr sheath.
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.
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 reported that the procedure was completed with a pipeline device.The cause of the failure to open was not determined.The pipeline had been placed in a vessel bend when it failed to open.

• 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: 22145471
• Report Number: 2029214-2025-01308
• Device Sequence Number: 7343140
• Product Code: OUT
• UDI-Device Identifier: 00763000284596
• UDI-Public: 00763000284596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: PED2-475-12
• Device Catalogue Number: PED2-475-12
• Device Lot Number: B818674
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/21/2025
• Date Device Manufactured: 11/14/2024
• 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: 86 YR
• Patient Sex: Female