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

Model Number	PED2-500-18
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-fg15 (lot: unkonwn); implant date n/a; explant date n/a 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 a pipeline flex with shield stent that failed to open.The patient was undergoing a procedure for flow diverter stent treatment of a right carotid artery unruptured saccular intracranial aneurysm.The aneurysm max diameter was 5mm; the neck diameter was also 5mm.Patient's vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).After access was established, the pipeline was delivered to the ipsilateral m1 segment.After 7-8mm of the pipeline stent tip was exposed and waiting approximately 10 seconds, the stent tip did not open.An additional 12mm fo the stent was deployed but the tip end still did not open.The surgeon attempted to retrieve and redeploy the stent as well as other maneuvers such as shaking, push/pull, and modifying catheter tension, but the stent still failed to open.The pipeline was then removed from the patient's body and the tip of the pipeline stent was found to be damaged/entangled.Due to the stent damage, there was concern of potential catheter damage as well, so both the stent and the catheter were replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.
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 reporting that the pipeline did not open at the distal section.The pipeline was not placed in a bend when it failed to open and was resheathed 0 times.There was not any resistance during delivery or retrieval of the pipeline.There was no reported damage or issue with the phenom 27 microcatheter.Catheter flush was administered during the procedure as indicated by the ifu.
Additional Manufacturer Narrative
H3: product analysis as found condition: the pushwire was returned inside a biohazard bag and a shipping box.There was no braid 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.No bend was found on the pusher.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 complaint was not confirmed, as the pushwire was returned without the braid.No damage was found with the pushwire.Possible causes of failure to open include vessel tortuosity or deploying the braid in the vessel bend.However, the customer reported that vessel tortuosity was moderate and the braid was not positioned in the vessel bend, which rules them out as potential causes.The root cause could not be determined.Since the braid was not returned, any contribution of the braid to the reported issue 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: 24037850
• Report Number: 2029214-2026-00055
• Device Sequence Number: 10276690
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: (01)00763000284718(17)280812(10)D057463
• 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): 03/03/2026

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: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: D057463
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 01/14/2026; 02/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/04/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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: 56 YR
• Patient Sex: Male