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

Model Number	PED2-400-18
Medical Device Problem Codes	Unintended Ejection (1234); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id ped2-400-16 (d063759); product type: implant date; explant date product id fg15150-0615-1s (231914451); 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
Medtronic received a report that the patient was undergoing treatment for a saccular, unruptured left clinoid c5 segment aneurysm with a max diameter of 6.3 mm and a 3.0 mm neck diameter.It was noted that the patient's vessel tortuosity was severe.The access vessel was the femoral artery, with 7.8mm diameter.The landing zone was 3.1mm distally and 4.0mm proximally.Dual antiplatelet treatment (dapt) was administered.The pru level was normal.It was reported that after the operator established access, a phenom 27 microcatheter was positioned in place.A shield ped400-18 device was unpacked and hydrated.The distal end of the device was advanced through the y-valve to the proximal/tail end of the phenom 27 microcatheter.While the assistant advanced the delivery wire to its full extent, very little resistance was noted.The distal end of the device was unable to enter the proximal/tail end of the phenom 27 microcatheter.The operator then withdrew the entire device onto the table and attempted to advance the delivery wire back and forth; however, the stent remained stationary.It was subsequently noted that the device had become detached (device detachment).The operator then replaced the device with a ped400-16 pipeline flow diverter stent.After hydration, the device was advanced to the c7 segment.In situ deployment was attempted.Deployment was initiated in the internal carotid artery by deploying the distal end.The operator slowly retracted the delivery catheter to expose the radiopaque markers.Subsequently, the delivery wire stabilized while the delivery catheter was withdrawn to deploy the distal end.However, the distal end failed to open.At that time, approximately 6 mm of the device had already been deployed.The operator then increased tension and advanced the delivery wire while fixing the phenom 27 microcatheter in an attempt to promote expansion, and an additional 4 mm of the distal end was deployed; however, the device still failed to open.The operator attempted to recapture the device and redeploy the distal end.During this process, the system migrated downward, and the operator did not reduce tension.Deployment of the distal end was changed to a tension-increasing technique.Approximately 10 mm of the distal end was deployed, showing a fusiform configuration with poor opening.Despite repeated adjustments with increasing and decreasing tension to promote expansion, the issue could not be resolved.For procedural safety, the entire system was withdrawn from the body.The device could not be removed from the phenom 27 microcatheter.A new device and a new phenom 27 microcatheter were then used, and the procedure was ultimately completed.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 an intermediate catheter ¿(b)(6), stryker guide wire.

• 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: 24982534
• Report Number: 2029214-2026-00732
• Device Sequence Number: 10505602
• Product Code: OUT
• UDI-Device Identifier: 00763000284350
• UDI-Public: (01)00763000284350(17)280622(10)D046737
• 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): 06/05/2026

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: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: D046737
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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 Sex: Unknown