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	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: ¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿as found condition: the pipeline flex shield pushwire was returned for analysis within shipping box; within a plastic bio-pouch; and within a dispenser coil.The pipeline flex shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: no bend was observed on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.No other anomalies were observed.¿ conclusion: based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at distal as the pipeline flex shield braid was not returned for analysis.However, the root cause could not be determined.It is likely the severe vessel tortuosity may have contributed to the reported issues.H6.Coding updated based on analysis findings.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 a pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured left cavernous carotid artery aneurysm with a max diameter of 4.8mm and a 4.1mm neck diameter.Landing zone: distal: 3.85mm and proximal: 4.76mm.It was noted the patient's vessel tortuosity was severe.Patient was noted to have a history of hypertension, hyperlipidemia.Dapt (dual antiplatelet treatment) was administered, conventional dual antibody.The angiographic result post procedure was normal.It was reported that the surgeon used a dense mesh stent to treat the aneurysm.After the stent catheter was delivered to the distal end of the middle cerebral artery m1, the stent was delivered and in place, and the stent was deployed from the straight section of m1.During the stent deployment process, the tip end failed to open smoothly.The surgeon then deployed the stent about 15 mm.The middle section of the stent opened, but the tip end still failed to open.The surgeon tried to wait and still failed to open.Then partially retrieved the stent and pulling the stent into the internal carotid artery, the tip end of the stent still failed to open.After re-retrieving the stent and deploying it again, it still failed.After multiple attempts, it was still unsuccessful and under fluoroscopy, the stent tip was found to be burred.The stent was removed from the body for safe operation.The stent tip was found to be damaged, and the operation was completed after replacing it with the ped2-475-18 stent.The pipeline was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.No additional steps or other devices were required to open the pipeline.The pipeline was removed from the patient.The pipeline was used for an indication that is approved (on-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.
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.

• 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: 22458156
• Report Number: 2029214-2025-01541
• Device Sequence Number: 15508426
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: (01)00763000284718(17)270920(10)B791122
• 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
• Report Date (Section B): 09/09/2025

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: B791122
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 57 KG