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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a right c5 segment unruptured saccular aneurysm using the pipeline embolization device, multiple deployment failures occurred.The procedure involved initial deployment of the pipeline embolization device 4.50mm x 25mm and a marksman catheter 150cm, with the catheter positioned 10 millimeters above the aneurysm.The stent's tip end was opened and anchored using push and pull techniques, but multiple attempts to open the stent at the midsection were unsuccessful.The stent was withdrawn into the catheter, and during retrieval with a recovery sheath, the stent could not move at the proximal end within the catheter.The physician released the load in the system in an attempt to resolve the issue but the issue did not resolve.The catheter was kinked in the distal section.The pushwire was not damaged the catheter was flushed continuously with heparinized saline.Both the catheter and stent were replaced.Subsequent attempts with new pipeline embolization device 4.50mm x 20mm and new catheter at the same location.The stent could not be opened, during the retrieval process with the recovery sheath, the stent could not move at the proximal end within the catheter.The tip end of the stent did not open initially.The catheter was withdrawn, and the stent was redeployed using a combination of push-and-pull techniques.The tip end opened and anchored, but at the midsection of the stent, multiple attempts to deploy it were unsuccessful.The proximal section failed to open.During the retrieval process with the recovery sheath, the stent could not move at the proximal end within the catheter.More than 50% of the pipeline was deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.A new microcatheter and dense mesh stent were then used instead, and the procedure was successfully completed.Dual antiplatelet treatment was administered, and angiographic results post-procedure confirmed the right c5 segment aneurysm.The aneurysm max diameter was 4.2mm and the neck diameter was 3.5mm.The distal landing zone was 3.94mm and the proximal landing zone was 4.2mm vessel tortuosity was moderate.The access vessel diameter was 7mm.The devices were prepared as indicated in the instructions for use (ifu).No patient symptoms, complications, adverse events, infections, or deaths were reported.No patient complications have been reported as a result of 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.
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 received reported a total of two pipelines and two marksman 150s failed to open.The third one did not experience issues and was deployed normally.The third one used a phenom 27 microcatheter.The pipeline was not placed in a vessel bend when it failed to open.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the pipeline flex shield embolization device and marksman catheter were returned for analysis within a shipping box; and within plastic bio-pouch.The pipeline flex was returned stuck within the marksman catheter.¿ damage location details: the pushwire extending out from catheter hub.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.In addition, the middle section of the braid was found to be fully opened and no damage.No flash or voids molded were observed in the hub.No damage was found with hub.The catheter body was found to be kinked at ~39.5cm from proximal end.In addition, the catheter body was found to be accordioned from ~31.5cm to ~28.0cm from distal end.The marksman catheter distal marker/tip was found to be flattened.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 pushwire ans braid from the catheter.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 as the pipeline flex shield and marksman catheter were found to be damaged.Possible causes include incompatible catheter, damaged catheter, burrs, bumps, kinks or other damage on ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, and users pulls back on/torques wire while advancing ped in microcatheter.It appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the marksman catheter against resistance.However, based on the analysis finding, the pipeline flex shield could not be confirmed to have failure to open at middle section as the missile section of the braid was found to be fully opened and no 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, 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: 22709969
• Report Number: 2029214-2025-01755
• Device Sequence Number: 8911750
• Product Code: OUT
• UDI-Device Identifier: 00763000284541
• UDI-Public: (01)00763000284541(17)270913(10)B787733
• 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): 10/28/2025

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: B787733
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 10/03/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/03/2025; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 68 KG