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

Model Number	PED2-450-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline flex stent failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery, ophthalmic artery segment a neurysm with a max diameter of 8.15 mm and a 4.66 mm neck diameter.The landing zone was 4.58 mm distally and 4.43 proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered at a normal reaction platelet reactivity units (pru) level.The angiographic result post procedure was good.It was reported that the lesion was an aneurysm at the ophthalmic artery segment of the left internal carotid artery.A ped2-450-20 was selected for implantation.After thorough hydration, the ped2-450-20 was delivered to the stent catheter.During deployment of the flow-diverting stent, the distal end of the stent didnot open well.Multiple attempts by the operator, including pushing and pulling, swinging back and forth, withdrawal and redeployment, had no noticeable effect.Repeated attempts to deploy the distal end of the stent were unsuccessful.Considering patient safety, the stent was replaced with a ped2-450-18 stent, but the distal end still did not open well and deployment was still not ideal.Similar pushing and pulling, swinging back and forth, withdrawal and redeployment were attempted, but the results were unsatisfactory.To ensure patient safety and the smooth progress of the procedure, the ste nt was replaced with a non-medtronic stent, after which the procedure was successfully completed.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.Ancillary devices include a microport 6f90 long sheath, ton-bridge medical 6f115 intermediate guide catheter, phenom 27 microcatheter, and a 450-20 jiushi shenkang stent.
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 received reported that the cause of the event was not determined.The pipeline had been placed in a vessel bend when it failed to open.Additional steps or other devices attempted to open the pipeline included pushing, pulling, swinging, retrieving, and re-deploying, but no other device was used to open it.
Additional Manufacturer Narrative
Product analysis ¿ as found condition: the pipeline flex shield was returned inside a biohazard bag and a shipping box.¿ visual inspection/damage location details: the distal and proximal dps restraints were intact, and the dps sleeves showed no signs of damage.Both the distal hypotube and the ptfe shrink tubing were also intact, with no signs of elongation.The distal and proximal ends of the braid were found open and frayed.The pushwire showed no bends, and there were no defects in the tip coil, distal marker, re-sheathing marker, re-sheathing pad, or proximal bumper.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the returned device, the customer report of "failure to open at the distal" was not confirmed, as the distal end of the braid was opened and frayed.The cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, damage to the braid, or deployment of the braid in a bend of the vessel.The customer noted that the vessel tortuosity was moderate, which rules it out as a possible cause.The customer also indicated that the braid was positioned in the vessel bend.Therefore, the deployment of the braid in the vessel bend and damaged braid contributed to the failure to open.Such damage can occur from resheathing the braid more than twice, over-manipulation, improper deployment techniques, pushing or pulling the delivery wire against resistance, or deploying or resheathing 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: 24225611
• Report Number: 2029214-2026-00193
• Device Sequence Number: 9265777
• Product Code: OUT
• UDI-Device Identifier: 00763000449384
• UDI-Public: (01)00763000449384(17)280828(10)D061411
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/22/2026

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: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: D061411
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 03/27/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/26/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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 Age: 58 YR
• Patient Sex: Male