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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding pipeline flex with shield embolization device that failed to open.The patient was undergoing a procedure for flow diverter stent treatment of an internal carotid artery (ica) c4 segment unruptured amorphous aneurysm.The aneurysm max diameter was 10mm and the neck diameter was 5.3mm.The distal landing zone was 4.5mm; the proximal landing zone was 4.9mm.Vessel tortuosity was moderate.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).After the catheter delivery system was positioned in lace, the pipeline was hydrated and delivered to the middle cerebral artery (mca) straight segment.The microcatheter was retracted to start deployment of the pipeline stent.However, the tip of the stent did not open.Deployment was continued with repeated pushing and pulling but the tip still did not open.The pipeline was fully resheathed in the microcatheter and repositioned at the proximal end of the posterior communicating artery (pcom) for deployment but the pipeline still did not open.The device was removed and replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Post-procedure angiography showed the treated blood vessels were in good condition with no rupture or stenosis observed.Ancillary devices: cerebase da 90cm sheath, navien 6f 115cm catheter, phenom 27 microcatheter, synchro guidewire.
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.The pipeline had not been placed in a vessel bend.There was no damage observed to the pipeline device after removal.
Additional Manufacturer Narrative
H6 updated product analysis #(b)(4):¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿drawing(s) referenced: n/a ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; and within a plastic bio-pouch.¿damage location details: no bent or kink was found with pushwire.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.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 was found fully opened and damaged.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 /incomplete open at distal as the device was resheated.In addition, the proximal and distal ends could not be identified.The 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 open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.The customer indicated that vessel tortuosity was moderate and the pipeline was not placed in a vessel bend.Which eliminates these factors out as potential causes.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: 24209703
• Report Number: 2029214-2026-00176
• Device Sequence Number: 12133564
• Product Code: OUT
• UDI-Device Identifier: 00763000449582
• UDI-Public: (01)00763000449582(17)280921(10)D066774
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: D066774
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 01/31/2026; 03/27/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/20/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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 Sex: Female