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

Model Number	PED2-500-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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 a pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the ophthalmic artery lateral wall, c4 with a max diameter of 5 mm and a 4 mm neck diameter.Landing zone: distal: 4.5 mm and proximal: 5.2 mm.It was noted the patient's vessel tortuosity was severe.The angiographic result post procedure showed serial aneurysms in the c5 and c6 segments.It was reported that the tip of the pipeline could not be opened inside the patient's body despite pushing, pulling, increasing or decreasing tension, the tip remained closed.After withdrawal from the patient's body, it could only be opened using a needle to pry it open.It was reported the pipeline failed to open in the distal section.The pipeline was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline had been resheathed more than 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient by resheathing and removing with the microcatheter.The pipeline was not used for an indication that is off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a phenom 27 microcatheter.
Additional Manufacturer Narrative
B5 updated with additional information received.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 the cause of the pipeline failure to open was not determined.It was considered possible that the stent may have been damaged due to repeated advancement attempts and patient's tortuous anatomy.
Additional Manufacturer Narrative
H3: product analysis: ¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿as found condition: the pipeline flex shield braid was returned for analysis within shipping box; within a plastic bio-pouch; within an opened pipeline flex shield inner pouch; and within a dispenser coil.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: the braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found to be fully opened and damaged.No other anomalies were observed.¿ conclusion based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal as the device was re-sheathed.In addition, the pipeline flex shield braid was found fully opened.The pipeline flex shield braid ends were found to be damaged.However, the root cause could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.The customer indicated that the pipelines had not been positioned in a bend.Which eliminates this factor out as potential causes.The vessel tortuosity was severe.It's possible that the severe vessel tortuosity may have contributed to the reported issue.In this event, the damaged braid may have contributed to the failure to open.The braid can become damaged due to resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause o f the braid damage could not be determined.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: 23905414
• Report Number: 2029214-2025-02686
• Device Sequence Number: 21323238
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: (01)00763000284725(17)280624(10)D047574
• 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
• Report Date (Section B): 02/23/2026

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: D047574
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/14/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/30/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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