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

Model Number	PED2-400-25
Medical Device Problem Codes	Unintended Ejection (1234); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 patient's arteries were tortuous, with short, sharp bends.After the stent was in place, it was discovered to be dislodged during deployment.The developing coil at the tip end of the stent did not move or change with the deployment of the stent, and the stent tip was not attached to the vessel wall.Based on experience, the surgeon determined the stent was dislodged and was unable to apply force to maintain adhesion.The surgeon then removed the stent from the body, reported the issue, and provided feedback.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an amorphous, unruptured segment of clinoid artery aneurysm with a max diameter of 9mm and a 6mm neck diameter.Landing zone: distal: 3.8mm and proximal: 4.1mm.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered using ticagrelor and aspirin dual antibiotics.Pru level met the standard.The angiographic result post procedure showed contrast agent retention at the aneurysm.Ancillary devices include an 8f cordis sheath, kai medtech lot number 2024050601 guide catheter, marksman lot number 229103207 microcatheter, and v-18 control wire, boston lot no.: m001468520 guidewire.
Event or Problem Description
Additional information received reported that surgery was completed by replacing the medtronic mesh stent with a new one.The customer believed there were two possible causes for the event: 1.There was a quality issue with the retrieval pads of our batch of mesh stents, causing multiple dislodgements.2.There was a quality issue with our marksman stent delivery catheter when navigating particularly tortuous blood vessels, causing problems with subsequent stents.It was noted there were difficulties in delivery and high resistance occurred in the tortuous section.It was clarified that there was no premature deployment; the stent was partially deployed distally and then withdrew to its designated position.The stent was not fully deployed; the deployment process involved pushing, and the stent was found to be immobile.The tip end was not fully opened and adhered to the wall.It was not placed on a site of tortuous blood vessels.The stent was not fully deployed, making it impossible to use other instruments.
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.
Event or Problem Description
Additional information received reported that the device did not jump during deployment.Following standard procedure, the microcatheter was withdrawn and the stent was deployed; no movement occurred.
Additional Manufacturer Narrative
H3: the pipeline pushwire was returned.No braid or catheter was returned with the pushwire.The distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared stretched, with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire from 45.0cm to 102.0cm from the distal tip coil.No damages were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.No other anomalies were observed.Based on the returned device, the customer's report of "failure to open at the distal end" could not be confirmed, as the pushwire was returned without the pipeline flex shield braid.The cause of the failure to open could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.However, the customer indicated that the braid was not positioned in the vessel bend, which eliminates it as a potential cause.In this event, the severe vessel tortuosity may have contributed to the failure to open.The damaged braid could not be ruled out as a possible cause.The customer's report of "resistance during delivery" was confirmed, as the pushwire was found to be damaged.The damage seen on the tip coil (kinking), pushiwre (kinking/bending), and hypotube (stretching) indicates that high force was applied.This damage may have resulted from the customer's attempts to deliver/retrieve the pipeline flex shield through the catheter while encountering resistance.Possible causes of resistance include severe vessel tortuosity and a lack of continuous flushing with heparinized saline during delivery.Since the marksman catheter was not returned, the catheter's contribution to the resistance could not be determined.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: 23360842
• Report Number: 2029214-2025-02262
• Device Sequence Number: 8965093
• Product Code: OUT
• UDI-Device Identifier: 00763000449216
• UDI-Public: (01)00763000449216(17)280610(10)D044560
• 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): 12/23/2025

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: PED2-400-25
• Device Catalogue Number: PED2-400-25
• Device Lot Number: D044560
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/01/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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: 58 YR
• Patient Sex: Female