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

Model Number	PED2-475-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report of pipeline failure to open in both distal and middle sections.The patient was undergoing surgery for treatment of a saccular, unruptured left, internal carotid artery, c6 segment, cerebral blood vessel aneurysm.It had a max diameter of 3 mm and a 4 mm neck diameter.The landing zone was 4.5 mm distally and 4.8 mm proximally.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered.The preoperative treatment with aspirin 300 mg combined with clopidogrel 75 mg for 5 days.The angiographic result post procedure was that the stentcould not be opened.It was reported that after the operator delivered the pipeline stent (ped2-475-16) to the target position and began deployment, the tip end of the stent could not fully open and appose the vessel wall, and the mid-portion failed to open entirely, making it impossible to continue the procedure.After multiple attempts, the operator had to replace the reported stent and select a new stent for subsequent treatment.A new stent was immediately used and successfully deployed and the procedure was completed.After the issue occurred during deployment of the first stent, a new stent was immediately used instead, and the procedure was completed successfully.There was failure to open in the middle and distal section of the stent.The pipeline was not positioned ina bend and less than 50% had been deployed when it failed to open the pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed with the microcatheter, and from the patient.There were no patient symptoms or complications associated with this event.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices include a neulive 6f gs-088-90-a sheath, a navien 6f rfx072-115-08mp, phenom27 g15150-0615-1s, stryker 0.014inx200cm m00326410.
Event or Problem Description
Any causes or contributing factors for the failure to open distally are unknown.Any causes or contributing factors for the failure to open in the middle section are also unknown.Multiple attempts were made to resheath, but it still could not fully 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.
Additional Manufacturer Narrative
H3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.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: 24680213
• Report Number: 2029214-2026-00509
• Device Sequence Number: 9855350
• Product Code: OUT
• UDI-Device Identifier: 00763000449452
• UDI-Public: (01)00763000449452(17)280924(10)D067969
• 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,Followup
• Report Date (Section B): 06/10/2026

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: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: D067969
• 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: 03/21/2026
• Supplement Date Received by Manufacturer: 03/24/2026; Not provided; 05/21/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/29/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG