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

Model Number	PED2-425-30
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the distal section of the pipeline failed to open and it was frayed.The patient was undergoing surgery for treatment of a saccular, unruptured a wide-neck aneurysm of the left ophthalmic segment with a max diameter of 4.5 mm and a 4.1 mm neck diameter.The landing zone was 3.8 mm distally and 4.2 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was standard dual antiplatelet therapy was within the therapeutic range.Postoperative angiography demonstrated good vessel patency with no abnormalities.It was reported that the operator used the stent to treat the aneurysm.The stent delivery microcatheter (phenom 27) was advanced to a distal position in the m1 segment of the middle cerebral artery, and the stent was delivered after hydration.According to the planned strategy of deploying the stent in the straight segment of the middle cerebral artery followed by pull back anchoring, the operator began deployment.After approximately 5¿7 mm of deployment, the distal tip end of the stent did not fully open.Further deployment was continued; however, while the proximal portion of the stent opened, the distal end remained inadequately opened, presenting a y shaped configuration.Partial resheathing followed by redeployment was recommended, but the distal tip end still failed to open.The operator then attempted complete pull back and redeployment of the stent; however, adequate opening was still not achieved.Under fluoroscopic imaging, fraying like damage was observed at the distal tip end of the stent.The stent was subsequently retrieved, and damage to the distal end was confirmed.The stent was replaced with a ped2 425 25 stent, and the procedure was completed successfully.The pipeline was resheathed and removed with the microcatheter from the patient.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed less than or equal to 2 times.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was not positioned in a bend.There was failure to open in the distal section of the pipeline.The device and any accessories were prepared as indicated in the ifu.The pipeline was used for an approved (on-label) indication.No patient symptoms or further complications were reported as a result of this event.
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.No causes or contributing factors for the failure to open or the observed damage were identified.
Additional Manufacturer Narrative
¿ updated b5, d9 ¿ h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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: 24611766
• Report Number: 2029214-2026-00445
• Device Sequence Number: 13315630
• Product Code: OUT
• UDI-Device Identifier: 00763000449315
• UDI-Public: (01)00763000449315(17)280608(10)D044174
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: PED2-425-30
• Device Catalogue Number: PED2-425-30
• Device Lot Number: D044174
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/23/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/11/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 77 KG