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

Model Number	PED2-475-25
Medical Device Problem Codes	Unintended Ejection (1234); Retraction Problem (1536); Material Separation (1562); Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
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 during retrieval the pipeline encountered resistance in the middle of the phenom.The patient was undergoing surgery for treatment of a saccular, unruptured right ophthalmic artery segment aneurysm with a max diameter of 4.6mm and a 9mm neck diameter.Landing zone: distal: 3.9mm and proximal 4.6mm.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered with pru level of 0.The angiographic result post procedure was normal.It was reported that the ped2-475-25 dense mesh stent was put to go upper to be in place through the phenom27 microcatheter, and the stent was deployed.After the stent tip was deployed, it was in a fish mouth shape and not fully opened.After multiple push and pull operations, the problem could not be solved, so it was decided to retrieve the stent and deploy the tip again.During the process of retrieving the stent into the microcatheter, it was obviously felt that there was a lot of resistance.After it was fully retrieved, it was found that the proximal end of the stent was separated from the retrieve mark point, and the proximal end of the stent was dislodged, so it was withdrawn from the body as a whole.The new phenom27 microcatheter and ped2-450-30 stent were replaced with, and the surgery was successfully completed.The pipeline did not become stuck.There was no catheter or pushwire damage.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared and the catheter was flushed continuously with heparanized saline as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
Product analysis: ¿as found condition: the pipeline flex shield braid and phenom 27 catheter were returned for analysis within shipping box; within a plastic bio-pouch; and within a dispenser coil.The pipeline flex shield pushwire was not returned for analysis.Therefore, any co ntributing factors could not be assessed.The pipeline flex shield braid returned stuck within catheter.¿damage location details: the distal and proximal ends of pipeline flex shield braid were found to be fully opened and damaged.No flash or voids molded were observed in the hub.The catheter body was found to be kinked at ~87.5cm from the proximal end.The catheter tip, marker band were examined; and no damage was found.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of phenom 27 catheter were measured to be within specifications.For further examination, the catheter was cut to remove the braid from the catheter lumen.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged location.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
H3: device received, analysis is in progress.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 that the cause of the resistance, failure to open, and damage was not determined.The distal part of the pipeline had failed to open.The pipeline was not positioned in a vessel bend at the time.They tried to retrieve the pipeline to get it to open, but it still had no effect.

• 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: 22204014
• Report Number: 2029214-2025-01368
• Device Sequence Number: 6755826
• Product Code: OUT
• UDI-Device Identifier: 00763000284640
• UDI-Public: (01)00763000284640(17)261109(10)B653353
• 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,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: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: B653353
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/31/2025; 06/15/2026; 06/15/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/25/2025; 06/15/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: 68 YR
• Patient Sex: Female