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

Model Number	PED2-450-12
Medical Device Problem Codes	Unintended Ejection (1234); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: drawing(s) referenced: n/a.As found condition: the pipeline flex shield braid was 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.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 braid ends were found fully opened and damaged.In addition, the middle section was found to be fully opened and no damage.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have ¿device opens prematurely¿ as the pipeline flex shield braid was found to be fully opened and damaged.Possible causes include resistance during delivery, high force delivery, operator did not have sheath properly seated in hub of microcatheter, over-manipulation, pushwire was torqued/pulled back during insertion or advancing ped inside microcatheter, and user resheaths device more than 2 times.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.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 patient was undergoing treatment for an aneurysm.It was reported that during delivery of the pipeline ped stent via the microcatheter, the stent was opened when introduced in the body before intended.The ped stent was removed, and a new device was used without issue.The angiographic result post-procedure was acceptable.It was unknown if 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 information was received.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The cause of the premature deployment was not determined.However, they indicated that the distal portion of the device was only partially open, presenting a ¿fishmouth¿ appearance.Premature deployment occurred when the device did not open fully at the distal end.The distal portion appeared to ¿fishmouth,¿.

• 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: 24339447
• Report Number: 2029214-2026-00278
• Device Sequence Number: 13204796
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: (01)00763000284503(17)261030(10)B648099
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B648099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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 Sex: Unknown