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

Model Number	PED2-500-30
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 operator advanced the phenom 27 to the m2 as per standard procedure and began delivering the devices.Due to a somewhat tortuous path, the operator advanced the microcatheter to a higher position and started delivering the stent.The operator reported some resistance during delivery, but the stent was still successfully positioned.When starting to deploy the stent, the operator first withdrew the microcatheter to about 9 mm; the stent¿s tip end was in the straight segment of the m1, but the tip end of the stent did not open.After waiting 40 seconds, the stent still did not open, so the entire system was pulled back to the internal carotid artery, but the stent still did not open.The operator then attempted retrieval and repeated the previous steps.The middle segment of the stent opened slightly, but the tip end had poor shape.The customer attempted to push the delivery guidewire, but the tip end of the stent still did not open.After repeated attempts, the tip end of the stent was completely deform ed, so the stent was replaced.The same issue occurred with the second stent.The operator then switched to a third stent with a 4.75 mm diameter.After following the standard procedure, the stent opened successfully and the procedure was completed.The pipelines were used for an indication that is approved (on-label).The reported devices 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 ophthalmic artery segment aneurysm with a max diameter of 7mm and a 7mm neck diameter.Landing zone: distal: 4.5mm and proximal: 4.9mm.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed that after the surgeon replaced the stent, the surgery was successfully completed, and the contrast agent remained significantly.Ancillary devices include a navien 6f115 guide catheter and phenom27 microcatheter.
Event or Problem Description
Additional information received reported clarification that the distal tip of the second pipeline also failed to open; no resistance was reported with the second pipeline.The catheter was flushed continuously during the procedure per the ifu.There was no damage observed to either pipeline pushwire.The pipeline was no positioned in a bend.No other steps or devices were used to try and open the pipeline stents.The cause of the event was not determined.
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.
Additional Manufacturer Narrative
H3: product analysis: as found condition: the two pipeline flex shield braids were returned for analysis inside a sealed biohazard bag and a shipping box.The two pipeline flex shield pusher wires were not returned with the pipeline braids.Damaged location details: both pipeline flex shield braids were returned already detached from the pusher wire; therefore, the distal and proximal ends could not be identified.Both ends of the pipeline flex shield braids were open and frayed.Both braids¿ middle sections were fully open without damage.No other anomalies were found.Testing/analysis: n/a conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ report could not be confirmed.As both the returned pipeline flex shield braids were already detached from the pusher wire, the distal and proximal ends could not be identified.Both ends of the braid 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 user deploying the braid in the vessel bend, and a damaged braid.In this event, the customer stated that the vessel tortuosity was moderate, and the pipeline was not positioned in a bend, which rules out vessel tortuosity and the user deploying the braid in the vessel bend as possible causes.Therefore, a damaged braid could have contributed to the reported failure to open.The braid can be damaged due to over-manipulation, re-sheathing more than twice, deployment techniques, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing the braid against resistance.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: 23498680
• Report Number: 2029214-2025-02354
• Device Sequence Number: 15701538
• Product Code: OUT
• UDI-Device Identifier: 00763000284749
• UDI-Public: (01)00763000284749(17)270227(10)B698594
• 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): 01/26/2026

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: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B698594
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 01/06/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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: 63 YR
• Patient Sex: Female