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

Model Number	PED2-475-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: phenom 27 microcatheter, product id fg15150-0615-1s (lot: 231914451); 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 a pipeline flex with shield technology stent could not be opened in the middle and posterior segment.Additionally, a phenom 27 microcatheter was difficult to navigate in tortuous anatomy.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, saccular, left c6 segment aneurysm with a max diameter of 4.5 mm and a 5 mm neck diameter.The landing zone arterial diameter was 4.5 mm distally and 4.9 mm proximally.It was noted the patient's vessel tortuosity was severe.Femoral artery access vessel diameter was 4.7 mm.Dual antiplatelet treatment (dapt) was administered.The platelet reactivity unit (pru) level was noted as normal.The angiographic result post procedure reported a left c6 segment aneurysm.It was reported that because the lesion was located at a left internal carotid artery c6 aneurysm and the vessel anatomy was severely tortuous, the phenom 27 microcatheter, under neuro guidewire guidance, was able to barely be guided into the distal middle cerebral artery after several attempts to perform deployment.The tip opening of the stent opened.The phenom 27 microcatheter was then retracted to approximately one-third of the stent length, and the stent was pulled back to the terminal internal carotid artery for positioning and deployment; at this point, the tip opening of the stent opened smoothly.The operator attempted to continue deploying the stent; however, upon reaching the tortuous segment of the vessel, the stent could not be opened.The operator therefore partially recaptured the stent and attempted redeployment, providing slack and then tension to the stent, but it still could not be opened.After several attempts, the stent barely opened, and the stent was then released normally.The operator continued to deploy the remaining portion of the stent and observed that the stent again could not be opened at that time.The operator repeated the above maneuvers several times and still found that the stent could not be opened.After multiple unsuccessful attempts, it was suggested to fully recapture and redeploy the stent.After several attempts, the proximal portion of the stent still could not be opened.The operator observed that the stent appeared difficult to open and recommended replacing both the stent and the phenom 27 microcatheter and redeploying.A new phenom 27 microcatheter and stent were therefore used instead.Under neuro guidewire guidance, the phenom 27 microcatheter again guided into the distal middle cerebral artery and deployment of the stent was initiated.The stent opening was observed to be open, so the stent was retracted to the terminal internal carotid artery to begin positioning and deployment, and the stent was observed to open normally.The remaining portion of the stent was then deployed.When the stent passed through the tortuous vessel segment, it was again observed that the stent could not be opened.The operator again attempted to increase tension and provide slack to the stent.After repeating these maneuvers several times, the stent within the tortuous vessel segment was observed to be in an open state, and deployment was initiated.The stent was successfully deployed, and the procedure was completed successfully.No patient symptoms or complications were associated with this event.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).

• 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: 24927661
• Report Number: 2029214-2026-00701
• Device Sequence Number: 5179786
• Product Code: OUT
• UDI-Device Identifier: 00763000449476
• UDI-Public: (01)00763000449476(17)280903(10)D062616
• 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: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/23/2026

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: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: D062616
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 62 YR
• Patient Sex: Female