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

Model Number	PED2-500-20
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 231405432); 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
Imedtronic received a report that the patient was undergoing treatment for a saccular, unruptured right internal carotid artery c6 segment aneurysm with a max diameter of 4.2 mm and a 4.9 mm neck diameter.The landing zone was 3.29 mm distally and 5 mm proximally.The access vessel was the right femoral artery, with 7mm diameter.It was noted that the patient's vessel tortuosity was moderate.A dual antiplatelet treatment (dapt) was administered.The pru level was one (1).It was reported that after endotracheal intubation under general anesthesia, the patient was placed in the supine position.Routine disinfection and draping of the groin area were performed.Successful right femoral artery access was obtained using the seldinger technique, and an 8f sheath was inserted.A 5f single-curve diagnostic catheter was guided to both internal carotid arteries and the left vertebral artery for anteroposterior and lateral angiography.3d rotational angiography was performed on the right internal carotid artery, with images acquired during the arterial, venous, and capillary phases.Intraoperative angiography revealed a saccular aneurysm in the c6 segment of the right internal carotid artery, measuring approximately 4.1 mm × 4.9 mm, with a neck of approximately 4.9 mm.No other significant abnormalities were identified on angiography.Based on the intraoperative angiographic findings, the surgical plan and procedural risks were discussed preoperatively with the patient¿s family.The family indicated understanding and consented to endovascular interventional embolization, and the informed consent form was signed.An 8f 90cm delivery catheter from likai company was then used, and rotational angiography of the right internal carotid artery was performed under the guidance of a multifunctional catheter.The working projection was selected based on the rotational angiography.An intermediate guide catheter ( rfx058-115-08, lot number d001764) was advanced to the cavernous segment of the right internal carotid artery.A microcatheter (fg15150-0615-1s, lot number 231405432) was advanced with the assistance of a synchro-14 micro-guidewire and successfully super-selected into the m1 segment of the left middle cerebral artery, with satisfactory positioning of the stent microcatheter.A ped2-500-20 flow diverter stent (lot number d068104) was introduced through the stent delivery catheter.Resistance was encountered during advancement, and during deployment, the tip end of the stent failed to open.The stent was resheathed and redeployed; however, after four repeated attempts, normal stent opening could not be achieved.Considering procedural safety, the microcatheter fg15150-0615-1s (lot number: 231405432) was used instead, and then the stent was advanced to the target lesion and deployment was initiated.When deployment progressed beyond halfway, the tip end of the ped2-500-20 stent (lot number d068104) still failed to open.Ultimately, the stent delivery catheter (fg15150-0615-1s, lot number 231405432) and the ped2-500-18 stent (lot number d065988) were used instead, which was successfully deployed, completely covering the aneurysm.Post-deployment angiography demonstrated significant contrast stasis within the aneurysm sac.The pipeline was not positioned in a bend.More than 50% of the pipeline was deployed when it failed to open and was resheathed more than two times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed with the microcatheter from the patient.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a navien guide catheter.
Additional Manufacturer Narrative
Updated b5, d9.H3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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 was received.No causes or contributing factors were identified for the resistance or for the failure to open.Resistance was noted at the distal portion of the catheter, and a kink was observed at the distal end after removal.No damage to the pipeline pushwire was observed.Re sheathing was attempted as an additional step to open the pipeline.

• 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: 24496465
• Report Number: 2029214-2026-00346
• Device Sequence Number: 12006881
• Product Code: OUT
• UDI-Device Identifier: 00763000449568
• UDI-Public: (01)00763000449568(17)280925(10)D068104
• 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,Followup
• Report Date (Section B): 05/06/2026

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: D068104
• 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: 02/28/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/22/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG