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

Model Number	PED2-475-18
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (unknown).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 a pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery c5 segment with a max diameter of 5.2mm and a 3.8mm neck diameter.The landing zone was 4.2mm distally and 4.9mm proximally.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed there was significant retention of contrast agent in the aneurysm.The procedure was successfully completed.It was reported that a dense mesh stent ped-475-18 was selected for implantation.During deployment, the stent could not open properly, even after more than 50% of the stent had been deployed.The tip end remained unable to open.The decision was made to withdraw and redeploy the stent, but it could not be retrieved, so the entire system was then removed from the patient.The pipeline was not positioned in a bend.The pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.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.Ancillary devices include a phenom microcatheter.
Additional Manufacturer Narrative
- updated b5, d9 - h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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 received.The cause of the failure to open and the resistance was not determined.A continuous saline flush was administered and maintained as indicated in the ifu.No damage to the pipeline pushwire or catheter was observed.
Additional Manufacturer Narrative
H3: product analysis ¿as found condition: the pipeline flex shield braid and phenom 27 returned for analysis within shipping box; within an opened pipeline flex shield outer carton; and within a dispenser coil.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.However, the pipeline flex shield braid was returned stuck within catheter hub.¿damage location details: the distal and proximal ends of pipeline flex shield were found fully opened and damaged.No flash or voids molded were observed in the hub.The catheter body was found to be kinked at ~3.8cm from distal ends.The catheter tip and marker band were examined; and no damage was found.No other anomalies were observed.¿testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was cut to remove the braid from the catheter hub.The catheter was flushed with water and water exited out from the distal tip.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal as the distal end of pipeline flex shield braid was found fully opened and damaged.However, the root cause for damage could not be determined.Possible causes of failure/incomplete to open include vessel tortuosity and damage braid.It was noted the patient's vessel tortuosity was severe.It is likely the severe vessel tortuosity may have contributed to the reported issues.Additionally, the pipeline flex shield could not be confirmed to have pushwire break/separation as the pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.There is no complaint against the phenom 27 catheter.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: 23988410
• Report Number: 2029214-2026-00023
• Device Sequence Number: 10717286
• Product Code: OUT
• UDI-Device Identifier: 00763000449469
• UDI-Public: (01)00763000449469(17)280825(10)D060517
• 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): 02/25/2026

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: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: D060517
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 02/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/11/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 44 KG