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

Model Number	PED2-500-18
Medical Device Problem Codes	Structural Problem (2506); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
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.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
Medtronic received a report that pipeline failed to open distally.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 7.6mm and a 3.7mm neck di ameter.The landing zone was 4.61mm distally and 4.93mm proximally.It was noted the patient's vessel tortuosity was moderate the access vessel was the femoral artery with 9.3mm vessel diameter.Dual antiplatelet therapy (dapt) was administered and the pru level was normal.It was reported that after the ped2 500 18 stent was advanced through a phenom 27 microcatheter to the m2 segment, the operator initiated deployment of the distal end at the m1 segment, making full use of the straight segment.The stent delivery catheter was slowly withdrawn to expose the distal radiopaque coil, and the microcatheter was further retracted to deploy the distal end of the stent.After approximately 6 mm of distal deployment, the stent failed to open properly.At that time, the tip of the delivery catheter had reached the terminal portion of the internal carotid artery.The operator continued to release a longer segment in an attempt to utilize the self expanding force of the stent to achieve opening.After approximately 13 mm of the stent was deployed within the internal artery, the distal end still failed to open.The operator attempted overall tensioning and detensioning maneuvers with gentle to and fro movements; however, the distal end remained unopened.The stent was then partially resheathed, and the distal end was redeployed by approximately 3 mm.The delivery catheter was immediately stabilized, and the delivery wire was advanced to increase tension.An additional 7 mm was released, but the stent still failed to open.Further overall tensioning and detensioning did not result in any improvement of the distal end.Subsequently, the operator withdrew the stent together with the phenom 27 microcatheter from the body.Upon extracorporeal inspection, deformation of both the microcatheter tip and the distal.The catheter was flushed and all devices were prepared as indicated in the ifu.The pipeline was not used for an indication that is not approved (off-label).No patient complications were associated with this event.Ancillary devices include a 0.014×2mm synchro guidewire, phenom 27 microcatheter, 6f 115 ton-bridge medical sheath.

• 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: 24859959
• Report Number: 2029214-2026-00655
• Device Sequence Number: 9238876
• Product Code: OUT
• UDI-Device Identifier: 00763000449551
• UDI-Public: (01)00763000449551(17)281008(10)D071478
• 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): 06/22/2026

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: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: D071478
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 04/21/2026; 05/28/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/19/2026; 05/19/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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 Sex: Female