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

Model Number	PED2-450-20
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm interventional treatment for an unruptured, saccular aneurysm located at the left ophthalmic artery, the pipeline embolization device 4.50mm x 20mm was advanced to the target location via the marksman catheter, starting from the straight segment of the middle cerebral artery.Upon deployment, the stent's tip was released approximately 8 millimeters in situ but failed to open properly and remained rod-shaped.The operator continued to deploy the stent up to 15 millimeters and attempted to push the stent to increase tension, but the stent still did not open.The operator then withdrew the stent as a whole to the internal carotid artery and continued deployment, hoping for self-expansion, but repeated pushing and pulling, as well as increased support from the intermediate catheter, did not resolve the issue.Further attempts to retrieve and redeploy the stent with a combination of pushing and pulling were unsuccessful.Eventually, the entire system was removed from the body, and during withdrawal, the st ent became stuck at the hub of the microcatheter.Angiography conducted post-procedure revealed contrast agent retention.No patient complications have been reported as a result of this event.The devices were prepared and flushed according to the instructions for use (ifu).The aneurysm max diameter was 6.2mm, and the neck diameter was 3.9mm.The landing zone was 3.6mm distal and 4.4mm proximal.The patient's vessel tortuosity was moderate.The access vessel was the femoral artery, which was 4.9mm in diameter.
Additional Manufacturer Narrative
Continuation of d10: product id fa-55150-1030 (lot: 228594242); product type; 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
Additional information received reported that the cause of the event was unknown.A continuous saline flush was administered and maintained as indicated in the ifu.No damage to the pipeline pushwire or catheter was observed.
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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 ¿ as found condition: the pipeline flex shield embolization device and marksman catheter were returned for analysis within a shipping box; within plastic bio-pouch; within an opened pipeline flex shield inner pouch; and within a dispenser coil.The pipeline flex shield pushwire was returned outside the marksman catheter.However, the pipeline flex braid was stuck within catheter hub.¿ 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 proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.The distal and proximal ends of the pipeline flex shield braid appeared to be fully opened and damaged.No flash or voids molded were observed in the hub.No damage was found with hub.The catheter body was found to be flattened from ~11.0cm to ~8.5cm from distal end.No damage was found with marksman catheter distal tip/marker band.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of marksman catheter were measured to be within specifications.For further examination, the catheter was cut to remove the braid from the catheter hub.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.¿ conclusion: based on the analysis findings, the pipeline flex shield and marksman catheter were confirmed to have resistance at hub as the pipeline flex shield braid was stuck within catheter hub.The pipeline flex shield and marksman catheter were found to be damaged.Possible causes include incompatible devices, material occludes hub, guidewire damage, hub damage (i.E.Hub gap, flash) and if device/material inserted into the hub is damaged.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the marksman catheter against resistance.In addition, based on the analysis finding, the pipeline flex shield could not be confirmed to have failure to open at distal as the distal and proximal ends of braid were found to be fully opened and damage.However, the root cause could not be determined.Possible causes of failure/incomplete to open include vessel tortuosity and damage braid.The marksman catheter is compatible to use with pipeline flex shield, the patient's vessel tortuosity was moderate, and the catheter was continually flushed with heparanized saline as indicated in the ifu.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: 23043979
• Report Number: 2029214-2025-02017
• Device Sequence Number: 10082650
• Product Code: OUT
• UDI-Device Identifier: 00763000284541
• UDI-Public: (01)00763000284541(17)271015(10)B803620
• 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): 11/29/2025

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: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B803620
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 11/05/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/25/2025; 11/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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 Sex: Female