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

Model Number	PED2-425-25
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a pipeline could not adhere to the vessel wall and could not be retrieved into the phenom microcatheter.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the left vertebral artery v4 segment with a max diameter of 5.3mm and a 4.2mm neck diameter.The landing zone was 3.1mm distally and 4.2mm proximally.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was normal.It was reported that the operator planned to use a pipeline to treat a dissecting aneurysm in the v4 segment of the vertebral artery.Due to the tortuous nature of the vessel, the stent did not adhere well to the vessel wall after deployment by the operator.An adjustment was made, and the stent was retrieved and redeployed, however, in the tortuous section of the vessel, the stent still failed to adhere to the vessel wall.The operator planned to retrieve the stent again and adjust the deployment position to resolve the vessel wall adhesion issue.However, it was found that the stent could not be retrieved in the tortuous section of the vessel.Under fluoroscopy, the stent was observed to deform during retrieval attempt and could not be moved to retrieve, leading to suspicion that the stent structure was damaged.To ensure surgical safety, the intermediate catheter was advanced to the tip end of the stent, and the stent was retrieved into the intermediate catheter.After that, the intermediate catheter, along with the microcatheter and the stent, were all removed as a whole from the patient's body.A new access was established, a new stent was used instead, and the procedure was completed.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 e vent.Ancillary devices include a skynor medical 6f115cm guide catheter and phenom 27 microcatheter.
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
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 that the the cause of the failure to adhere to wall and failure to retrieve was not determined.A continuous saline flush was administered and maintained as indicated in the ifu.The distal end of the delivery wire was kinked.The middle section of the pipeline did not open.The pipeline was placed in a vessel bend when it failed to adhere.Additional steps or other devices attempted to adhere the pipeline included attempts using pushing and pulling motions.The phenom was continued to be used to deploy another pipeline and then sterilized and handled by the hospital.
Additional Manufacturer Narrative
H3 ¿ analysis: as found condition: the pushwire was returned inside a biohazard bag and a shipping box.There was no braid or catheter 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.The pushwire appeared to be bent at 11.5cm from the distal tip coil.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 customer report of "failure to open" and "resistance during retrieval" was not confirmed, as the pushwire was returned without the braid or catheter.The returned pushwire was found to be bent.However, the cause for damage could not be determined.Possible causes of failure to open include severe vessel tortuosity and deployment of he braid in the vessel bend.The possible causes of the resistance include severe vessel tortuosity.The customer indicated that a continuous flush was used, which rules it out as a potential cause.Since the braid and catheter were not returned, their contribution to the reported issues 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.

• 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: 24067013
• Report Number: 2029214-2026-00070
• Device Sequence Number: 13358588
• Product Code: OUT
• UDI-Device Identifier: 00763000284466
• UDI-Public: (01)00763000284466(17)280617(10)D046402
• 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): 03/12/2026

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: PED2-425-25
• Device Catalogue Number: PED2-425-25
• Device Lot Number: D046402
• 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: 01/10/2026
• Supplement Date Received by Manufacturer: 01/15/2026; 02/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/06/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: 53 YR
• Patient Sex: Male