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

Model Number	PED2-475-25
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id ped2-450-30 (b742460).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 information regarding two pipeline flex with shield stents that failed to open.The patient, who had multiple aneurysms in the internal carotid artery (ica) ophthalmic segment, was undergoing a procedure for flow diversion treatment of a ruptured amorphous aneurysm.The max diameter was 5mm and the neck diameter was 3mm.The distal landing zone was below the ica bifurcation and the proximal landing zone was in the cavernous sinus straight segment.Patient's vessel tortuosity was severe.It was reported that the pipelines and all accessory devices were prepared as indicated in the instructions for use (ifu).Per the vessel measurement, ped2-475-25 was selected.The stent was delivered in the m2 and the pipeline was delivered.The microcatheter was withdrawn until about 15mm of the pipeline stent was exposed, but the pipeline did not open; the tip was rod-shaped.The device was pulled back to the ica and deployment continued.The tip end was able to be anchored then but at the bend of the ophthalmic artery, the stent again appeared rod-shaped and could not be opened despite push and pull maneuvers.The pipeline was removed.A new microcatheter was then used to deliver a different size pipeline, ped2-450-30.However, this pipeline stent remained rod-shaped and could not be opened.This pipeline too was retrieved.Another manufacturer's device was then used to complete the procedure.There was not harm or injury to the patient associated with this event.Ancillary device: marksman microcatheter.
Event or Problem Description
Additional information was received.The first pipeline (ped2-475-25) failed to open in the middle section, while the second pipeline (ped2-450-30) failed to open at the tip end.The blood vessels presented with some curvature, though not severe.No additional devices or steps, such as resheathing, wire/catheter manipulation, or balloon assistance, were attempted beyond one resheathing attempt.No resistance was encountered during delivery of the pipeline, and no resistance or issues were reported with the marksman microcatheter.The cause of the pipeline failure to open was not definitively determined; however, the surgeon suspected that kinking of the stent contributed to the issue, as pushing and pulling maneuvers were ineffective.
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
Product analysis #(b)(4): ¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; within a plastic bio-pouch; within an opened pipeline flex shield inner pouch; and within a dispenser coil.¿damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found to be fully opened and damaged.In addition, the middle section of the braid was found to be fully opened and no damage.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure to open at middle section as the middle section of the braid was found to be fully opened and no damage.Is likely the severe vessel tortuosity may have contributed to the reported issue.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: 22777635
• Report Number: 2029214-2025-01794
• Device Sequence Number: 9119971
• Product Code: OUT
• UDI-Device Identifier: 00763000284640
• UDI-Public: (01)00763000284640(17)270701(10)B754087
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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: PED2-475-25
• Device Catalogue Number: PED2-475-25
• Device Lot Number: B754087
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 09/25/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 67 YR
• Patient Sex: Male