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

Model Number	PED2-500-20
Medical Device Problem Codes	Material Frayed (1262); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 after the distal end of the stent was opened, the proximal end remained bar-shaped and failed to open.Various manipulation techniques were attempted but could not open it, and the front end was found to be frayed.Ancillary devices include a 8f cordis guide catheter, marksman microcatheter, synchro14 guidewire.There was failure to open in the middle section.The pipeline positioned was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than two times.There were no additional steps or other devices required to open the pipeline.  the pipeline was removed from patient.The pipeline was resheathed and removed with the microcatheter.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an approved indication.The device and any accessories were prepared as indicated in the ifu.    the patient was undergoing surgery for treatment of a saccular, unruptured ophthalmic artery segment aneurysm with a max diameter of 8 mm and a 6 mm neck diameter.The landing zone was 4.2 mm distal and 5.1 mm proximal.It was noted the patient's blood flow was xxx and vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level met standards.The angiographic result post procedure was no damage.
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 cause of the failure to open and the resulting damage was not determined.The middle section of the pipeline could not be opened, and the stent had also become unloaded and was therefore taken out directly.
Additional Manufacturer Narrative
Product analysis ¿ as found condition: the pipeline flex device was returned within a shipping box, a plastic bio-pouch, an open pipeline flex inner pouch, and a dispenser coil.¿ visual inspection/damage location details: no bends, kinks or stretching was found with the pipeline flex pusher.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The pusher distal segment (resheathing pad, sleeves, and tip coil) was not returned.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The distal and proximal ends of pipeline flex braid were found to be fully open and damaged (frayed).¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete to open at middle section¿ report could not be confirmed.The returned pipeline flex braid was found open.However, the customer¿s ¿pipeline damaged¿ report was confirmed as the braid was found damaged (frayed).Possible causes of ¿failure/incomplete to open at middle section¿ include patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.Possible causes of ¿pipeline damaged¿ include resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.The device was not in a bend when deployed, the vessel tortuosity was described as moderate, and there was no report of resistance during delivery or deployment against resistance.Therefore, it is likely that the resheathing of the pipeline flex device more than two times contributed to the reported event.Regarding pusher detachment, potential causes include patient vessel tortuosity, resistance/high force delivery, catheter damage, or user resheaths more than 2 times.The vessel tortuosity was described as moderate and there was no report of resistance during delivery.The catheter used in the event was not returned.Therefore, any contributing factors could not be assessed.Therefore, it is likely that the resheathing of the pipeline flex device more than two times contributed to the pusher detachment.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: 22730142
• Report Number: 2029214-2025-01767
• Device Sequence Number: 13003728
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: (01)00763000284725(17)270809(10)B771747
• 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
• 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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B771747
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 09/23/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male