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

Model Number	PED2-400-25
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026); Activation Failure (3270); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 the surgery was prepared according to protocol, but the stent could not be deployed during the procedure.The pipeline failed to open in the proximal 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 was resheathed more than 2 times.No additional steps or other devices were required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.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.The patient was undergoing surgery for treatment of a saccular, unruptured anterior intracranial circulation aneurysm with a max diameter of 4.0mm and a 2.5mm neck diameter.Landing zone: distal: 10mm and proximal: 10mm.It was noted the patient's vessel tortuosity was normal.The angiographic result post procedure was satisfactory after replacing the product.
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.The procedure was performed via a percutaneous radial artery approach.Under dsa fluoroscopic guidance, the delivery system was advanced along the guidewire to the target lesion, and the device was delivered and positioned according to the standard steps outlined in the product¿s instructions for use.The cause id the deployment failure was determined that the angiography revealed that the stent had migrated into the aneurysm and could not be retrieved.Another stent was subsequently placed, and angiography showed good stent apposition and normal blood flow.
Event or Problem Description
Additional information received.During retrieval, resistance was encountered in the distal section of the catheter.Additionally, a continuous saline flush was administered and maintained throughout the procedure, as indicated in the instructions for use (ifu).The used catheter was a non-medtronic device.
Additional Manufacturer Narrative
Product analysis as found condition: the pipeline flex shield braid and xt-27 non-medtronic catheter were returned for analysis withing shipping box; within a plastic bio-pouch; and within an opened pipeline flex shield inner pouch.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.The pipeline flex shield braid was returned within the xt-27 catheter hub.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 fully opened and damaged.No damage was found with xt-27 catheter.No other anomalies were observed.Testing/analysis: the pipeline flex shield braid was removed from the xt-27 catheter without any issue.Conclusion: based on the analysis finding, the pipeline flex shield could not be confirmed to have failure to open at proximal as the device was resheated.In addition, the pipeline flex shield braid ends were found fully opened and damaged.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.However, the customer indicated that vessel tortuosity was normal, which eliminates this factor out as potential causes.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.In addition, the pipeline flex shield could not be confirmed to have resistance during retrieval as the pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.However, the root cause for resistance could not be confirmed.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: 23774415
• Report Number: 2029214-2025-02605
• Device Sequence Number: 10080123
• Product Code: OUT
• UDI-Device Identifier: 00763000284374
• UDI-Public: (01)00763000284374(17)270807(10)B770548
• 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): 02/13/2026

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: PED2-400-25
• Device Catalogue Number: PED2-400-25
• Device Lot Number: B770548
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/22/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 60 KG