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

Model Number	PED2-500-25
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 the phenom27 microcatheter was guided by the nerve guidewire and was pushed to go upper to the end of the left middle cerebral artery m1, and the micro-guidewire was withdrawn.After the ped2-500-25 dense mesh stent was fully hydrated, it was delivered and pushed to go upper through the phenom27 catheter.The stent had a large resistance when passing through the cavernous sinus of the internal carotid artery.The surgeon observed that the access system was stable and normal, and continued to deliver the stent to the end of the microcatheter with a certain tension.The phonm27 was withdrawn in situ in the straight section of m1 to deploy the stent.It was observed that the tip end was fish-mouthed and not opened.More length was deployed and a certain tension was applied to push the stent, but the problem could not be solved.Then the stent was completely retrieved into the microcatheter, the middle catheter was pushed to go upper, and it was deployed again.At this time, there was obvious resistance during the deploy process, and the tip end of the stent still could not be opened.It was found that the tip end of the stent was abnormal, and the stent was completely retrieved and withdrawn from the body.After replacing it with the new ped-500-25 stent, the operation was successfully completed.The pipeline was used for an approved (on-label) indication.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery aneurysm with a max diameter of 6.98 mm and a 4.32 mm neck diameter.The landing zone was 4.33 mm distal and 4.97 mm proximal.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level 0.The angiographic result post procedure was normal.
Event or Problem Description
Additional information was received stating that the cause of the resistance, damage, and failure to open was not determined.Resistance occurred in the distal section of the catheter.A continuous saline flush was administered and maintained as indicated in the ifu.No damage to the pipeline pushwire or catheter was observed.The pipeline had not been placed in a vessel bend when it failed to open.No additional steps or other devices were attempted to open the pipeline.
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
Product analysis:(b)(4),lot :b721602 ¿ as found condition: the pipeline flex shield was returned inside a biohazard bag and shipping box.The phenom 27 catheter was not returned.¿ visual inspection/damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The braid's distal and proximal ends were found to be open and frayed.No bends were found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad, or the proximal bumper.No other anomalies were observed.¿ conclusion: based on the device analysis and reported information, the customer report of ¿failure/incomplete open distal¿ was not confirmed, as the braid's distal end was open and frayed.The cause of the ¿failure/incomplete open¿ could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, or deployment of the braid in the vessel bend.However, the customer indicated that vessel tortuosity was moderate, and the braid was not positioned in the vessel bend, which eliminates these factors as potential causes.In this event, the damaged braid may have contributed to the failure to open.The braid can become damaged due to over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause of the braid damage could not be determined.The customer report of "resistance during delivery" was not confirmed, as the pipeline flex shield was returned without the catheter.No damage was found with the pushwire.Possible causes of the resistance during delivery include vessel tortuosity and lack of a continuous flush with heparinized saline during delivery.The customer indicated that the vessel tortuosity was moderate, and a continuous flush was used, which eliminates these as potential causes.The cause of the resistance could not be determined.Since the catheter was not returned, any contribution of the catheter to the resistance issue could not be assessed.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: 22169909
• Report Number: 2029214-2025-01331
• Device Sequence Number: 7788997
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: 00763000284732
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

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: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B721602
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/31/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/23/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: 67 YR
• Patient Sex: Female