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

Model Number	PED2-400-20
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for a saccular, unruptured c6 segment aneurysm with a max diameter of 5 mm and a 6 mm neck diameter.The landing zone was 3.56 mm distally and 4.1 mm proximally.It was noted that the patient's vessel tortuosity was mild.The access vessel was the femoral artery, with 7.2mm diameter.Dual antiplatelet treatment (dapt) was administered.The pru level was unknown.It was reported that by following standard procedure, the operator advanced the phenom27 catheter to the distal m1 segment.A ped2-4-20 stent was then delivered.After the stent was positioned, the microcatheter was withdrawn approximately 15 mm, at which point the distal end of the stent failed to open properly.The operator subsequently followed the standard procedural steps to resheath and attempt redeployment.Although the distal portion of the stent partially opened, it could not be fully deployed.It was suspected that the distal end of the stent might have been damaged.The stent was then removed from the body, and inspection confirmed damage to the distal end, preventing full expansion.The device was replaced with a ped2-3.75-25 stent, which was successfully deployed on the first attempt, and the procedure was completed uneventfully.The angiographic result post procedure was normal.It was unknown if the pipeline used for an indication that is not approved (off-label).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.Ancillary devices include a achieva medical guide catheter, stryker guidewire.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 232045494); implant date n/a; explant date n/a.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 reporting that no causes or contributing factors for the damage were identified.No friction or difficulty during delivery or positioning.The pipeline had not been placed in a vessel bend when it failed to open.No additional steps or other devices were attempted to open the pipeline beside resheathing.The stent damage was observed as, "damage to the distal structure." no obvious abnormalities were observed with the p27.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when 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: 24663115
• Report Number: 2029214-2026-00498
• Device Sequence Number: 18463967
• Product Code: OUT
• UDI-Device Identifier: 00763000449209
• UDI-Public: (01)00763000449209(17)280701(10)D049316
• 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
• Report Date (Section B): 05/28/2026

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: PED2-400-20
• Device Catalogue Number: PED2-400-20
• Device Lot Number: D049316
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/01/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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 Sex: Male