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

Model Number	PED2-475-35
Medical Device Problem Codes	Structural Problem (2506); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for a saccular, unruptured aneurysm c6 segment of the right internal carotid artery with a max diameter of 12.7mm and a 6.3 mm neck diameter.It was noted that the patient's vessel tortuosity was moderate.The landing zone was 3.9mm distally and 4.6mm proximally.It was reported that under guidewire guidance, the phenom 27 catheter formed a loop within the aneurysm and was then advanced into the distal parent vessel, followed by the intermediate catheter.After unlooping, the first stent (475-35) was selected and deployed successfully.Slight distal shortening was observed, raising concerns about distal anchoring.Therefore, it was decided to place an additional dense mesh stent as a bridge.Under guidewire guidance, the microcatheter was advanced through the first dense mesh stent, and the deployment of the second dense mesh stent was initiated.However, the second stent could not be opened at the distal section despite various maneuvers such as manipulation and repositioning.The dense mesh stent was then retrieved and removed from the body.After replacing it with a new stent, the procedure was completed successfully.The pipeline was not positioned in a bend.More than 50% of the pipeline was deployed when it failed to open and was resheathed less than or equal to two times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed with the microcatheter from the patient.The pipeline was used for an indication that is approved (on-label).The angiographic result post procedure shows that there was significant contrast agent retention in the aneurysm, and the stent morphology appeared normal.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.
Additional Manufacturer Narrative
Continuation of d10: product id (d035756).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 was received stating that the cause of the failure of opening was not determined, suspected damage to the tip.Retrieved and attempted to reopen, but it still could not be opened.No additional resistance was noted during deployment.
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 was received stating that only the ped that failed to open had damage at the tip.The cause of the distal shortening was not determined.
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: 23743446
• Report Number: 2029214-2025-02557
• Device Sequence Number: 8421336
• Product Code: OUT
• UDI-Device Identifier: 00763000284664
• UDI-Public: (01)00763000284664(17)280325(10)D028417
• 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 Explanted Year: 2025
• 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): 02/25/2026

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: PED2-475-35
• Device Catalogue Number: PED2-475-35
• Device Lot Number: D028417
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/13/2026; 01/30/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/03/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 47 KG