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

Model Number	PED2-475-16
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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
Medtronic received a report that a pipeline flex with shield technology stent (ped2) was deployed at the landing zone, however, the distal end wouldn't open.The stent was recaptured and the system was advanced up more distally into the m1 segment and deployment was attempted again but the device was still not opening.The device looked irregular under fluoroscopic imaging and the physician opted to resheath the device and remove it from the patient with the microcatheter.Once device was removed and laid on the back table, the device looked pinched on the distal end.The stent was replaced with a different size ped2 to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, saccular, right internal carotid artery (ica) aneurysm.The landing zone arterial diameter was 3.37 mm distally and 4.7 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.The angiographic result post procedure showed successful implant of the replacement device.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).The distal portion of the pipeline was positioned in a bend, less than 50% of the pipeline had been deployed when it failed to open, and the pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.
Additional Manufacturer Narrative
¿ updated b5, d9, ¿ e: phone nubmer and email address ¿ h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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.The patient was treated for saccular, right internal carotid artery (ica) aneurysm.The cause of the stent failure to open and the damage were not determined.
Additional Manufacturer Narrative
Product analysis ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; and within an opened pipeline flex shield outer carton and inner pouch.¿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.One of the ends of pipeline flex shield braid appeared to be not opened due to damaged braid.The other end of the pipeline flex shield braid was found fully opened and damaged.In addition, the middle section was found to be not fully 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 distal (flex) as the device was resheated.In addition, the proximal and distal ends could not be identified.However, one of the ends of pipeline flex shield braid appeared to be not opened due to damaged braid.In addition, the middle section was found to be not fully opened and damaged.However, the root cause could not be determined.Possible causes include patient vessel tortuosity, braid damage, braid deployed in vessel bend.It was noted that the patient's vessel tortuosity was moderate.Which eliminates this factor out as potential causes.(nikkhs2 2026-02-23).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: 24043523
• Report Number: 2029214-2026-00057
• Device Sequence Number: 9260152
• Product Code: OUT
• UDI-Device Identifier: 00763000449452
• UDI-Public: (01)00763000449452(17)280324(10)D028114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: D028114
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/28/2026; 02/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/17/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: 60 YR
• Patient Sex: Female