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

Model Number	PED2-450-18
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
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 microcatheter was in place, and stent delivery and tip deployment were normal.However, a kink occurred in the cavernous sinus segment during mid-segment deployment.Multiple adjustments and retrievals, re-deployed all failed to open, raising concerns about thrombosis at the kink site.For safety reasons, the entire stent was retrieved.Re-selected a 4.5-16 stent, it was then successfully delivered and deployed.The pipeline failed to open in the middle 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.There were no additional steps or other devices 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 left ophthalmic artery aneurysm with a max diameter of 5.5mm and a 4.5mm neck diameter.Landing zone: distal: 3.7mm and proximal 4.3mm.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was not administered.The angiographic result post procedure showed aneurysm angiography fluid retention, blood vessel patency was normal.
Event or Problem Description
Additional information was received that the cause of the kink and failure to open was not determined.It was clarified that there was no thrombosis at the kink site.
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.
Additional Manufacturer Narrative
H3 product analysis: ¿ as found condition: the pipeline flex shield device was returned for analysis inside a sealed biohazard bag and a shipping box.¿ damaged location details: the pipeline flex shield tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were intact, with no damage.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation or damage.No bends or kinks were found on the pusher wire.The braid was already detached from the pusher wire when it was returned; therefore, the distal and proximal ends could not be identified.Both braid ends were open and frayed.The braid¿s middle section was fully open without damage.No other anomalies were found.¿ conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at middle¿ report could not be confirmed, as the middle section of the returned pipeline flex shield braid was fully open without damage, while both braid ends were open and frayed.However, the cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, the braid improperly sized for the anatomy, the braid overstretched during delivery, the user deploying the braid into the vessel bend, or a damaged braid.In this event, the customer reported that the vessel tortuosity was moderate, and the pipeline was not positioned in a bend, ruling out vessel tortuosity and the user deploying the braid in the vessel bend as possible causes.Therefore, an improperly sized braid for the anatomy, an overstretched braid during delivery, and a damaged braid could have contributed to the failure to open.The braid can be damaged by over-manipulation, re-sheathing more than twice, deployment techniques, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing against resistance.However, the cause of the braid damage could not be determined.However, the cause of 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: 23693571
• Report Number: 2029214-2025-02522
• Device Sequence Number: 13059781
• Product Code: OUT
• UDI-Device Identifier: 00763000284534
• UDI-Public: (01)00763000284534(17)280907(10)D062848
• 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): 02/04/2026

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: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: D062848
• 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: 11/30/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/29/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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: Male