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 Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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 after advancing the ped-500-20 stent through the marksman to the m2 segment, the operator began deploying the tip end at the m1 segment, taking advantage of the straight portion.The stent delivery catheter was slowly withdrawn to expose the proximal radiopaque marker coil.The microcatheter was further withdrawn to release the stent tip end, but after deploying approximately 6 mm, the stent failed to open properly.The operator continued to deploy a longer segment, attempting to utilize the stent's self-expansion force to open, and deployed about 16 mm, at which point the delivery catheter tip reached the internal carotid artery, but the stent tip still failed to open.Suspecting that the small wings at the stent tip were constraining it, the operator retrieved the stent and attempted in vivo flipping of the small wings, then redeployed the stent.After withdrawing the stent delivery catheter to expose the radiopaque marker coil and deploying about 5 mm, the operator advanced the delivery guidewire and continued to deploy 4 mm, but the stent still failed to open.The operator then pulled the whole stent to the distal end of the internal carotid artery, continued to deploy up to 17 mm, but the stent tip end still did not open.Subsequently, the operator removed both the stent and the marksman from the body.Upon pushed out the stent in vitro, it was found that both the microcatheter tip and the stent tip had become deformed.A new ped2-500-18 stent was then selected, and the procedure was completed successfully.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for flow diverter stent implantation for aneurysm treatment of an amorphous, unruptured right clinoid segment aneurysm with a max diameter of 6.3mm and a 6.1mm neck diameter.Landing zone: distal: 4.3mm and proximal: 4.9mm.It was noted the patient's vessel tortuosity was moderate.Access vessel was the femoral artery with a 9.1mm diameter.Dapt (dual antiplatelet treatment) was administered.Pru level (p2y12 reaction unit) was normal.The angiographic result post procedure showed the stent was well apposed to the vessel wall, and there was significant contrast agent retention.Ancillary devices include a 6f 90 cm long sheath, bard medical, 150 marksman microcatheter, 0.014×2mm synchro guidewire, 6f 115 navien.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 reporting that the cause of the event was determined to be the because of the damage to the stent tip.The pipeline failed to open in the distal section of the device.The pipeline had not been placed in a vessel bend when it failed to open.No additional steps or other devices were attempted to open the pipeline.
Additional Manufacturer Narrative
H3 product analysis: ¿ as found condition: the pushwire was returned within the inner pouch, a biohazard bag and a shipping box.There was no braid returned with the pushwire.¿ visual inspection/damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation.No bend was found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker, or proximal bumper.No other anomalies were observed.¿ conclusion: based on the returned device, the pipeline flex shield was not confirmed to have failure to open at the distal end, as the pushwire was returned without the braid.No damage was found with the pushwire.Possible causes of failure to open include vessel tortuosity and deployment of the braid in the vessel bend.However, the customer reported that vessel tortuosity was moderate and the braid was not positioned in the vessel bend, which rules them out as potential causes.The root cause could not be determined.Since the braid was not returned, any contribution of the braid to the reported issue 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: 24290910
• Report Number: 2029214-2026-00243
• Device Sequence Number: 21184189
• Product Code: OUT
• UDI-Device Identifier: 00763000449568
• UDI-Public: (01)00763000449568(17)281013(10)D072575
• 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: 2026
• Device Explanted Year: 2026
• 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): 04/21/2026

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: D072575
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 03/27/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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