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

Model Number	PED2-450-20
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after surgical evaluation, the customer decided to use our dense mesh stent for treatment.Based on preliminary data measurements, a ped2-450-20 dense mesh stent was selected for the procedure.After device hydration, the phenom27 (p27) microcatheter was positioned at m2, and device delivery began.Once the stent was positioned along the microcatheter, the customer began stent deployment.The customer began retracting the phenom27, approximately 8mm, with the stent tip at the level of m1.However, the stent morphology did not show opening.The customer waited 30 seconds, but it still did not open.The customer repeated the retraction and procedure, but the stent morphology remained unchanged.Therefore, the guidewire delivery method was changed.The stent tip morphology was problematic.The customer believed the stent had been damaged during delivery, so the entire p27 and stent were removed, replaced with a new p27 and a new stent.Subsequent procedures proceeded normally, the stent opened successfully, and the surgery was completed smoothly.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for dense mesh stent implantation of a saccular, unruptured ophthalmic artery segment aneurysm with a max diameter of 7mm and a 5mm neck diameter.Landing zone: distal: 4.3mm and proximal: 4.6mm.It was noted the patient's vessel tortuosity was moderate.Access vessel was the femoral artery.Dapt (dual antiplatelet treatment) was administered.After the customer replaced the stent, an angiography was performed on both the anteroposterior and lateral sides.The angiography result post procedure showed that there was significant retention of contrast agent in the aneurysm, and all the blood vessels were there.Ancillary devices include a navien 5f115, 6f115 guide catheter and phenom27 microcatheter.
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 there was some resistance in the phenom during pipeline delivery.There was no problem with the navien catheter.The pipeline was not placed in a bend when it failed to open.It was clarified that the distal end of the pipeline failed to open due to the distal stent being damaged.
Additional Manufacturer Narrative
B5 updated with additional information received.H6.Coding updated based on additional information received.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
H2: analysis cannot be completed as device was not returned.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
No new additional received.

• 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: 23497438
• Report Number: 2029214-2025-02346
• Device Sequence Number: 18390504
• Product Code: OUT
• UDI-Device Identifier: 00763000449384
• UDI-Public: (01)00763000449384(17)280609(10)D044541
• 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: 2025
• 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
• Report Date (Section B): 02/03/2026

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: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: D044541
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 02/02/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/05/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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: 55 YR
• Patient Sex: Female