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

Model Number	PED2-450-35
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a pipeline flex with shield that had resistance with the phenom 27 microcatheter and failed to open.The patient was undergoing a procedure via right femoral artery access for flow diverter treatment of an internal carotid artery (ica) c5 segment unruptured saccular aneurysm.The aneurysm max diameter was 20.5 mm and the neck diameter was 11 mm.The distal landing zone was 3.8 mm; the proximal landing zone was 4.6 mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the devices were prepared and catheter was flushed as indicated in the instructions for use (ifu).The phenom 27 microcatheter was delivered with the guidewire to the middle cerebral artery (mca) m3 segment.The pipeline was then delivered but, upon deployment, when the pipeline was less than 50% deployed, the pipeline stent distal end failed to open fully despite multiple attempts.The entire system was pulled back to the end of the ica c7 segment but the stent could still not be opened fully and could not achieve adequate wall apposition.The pipeline was not positioned in a bend.The pipeline was resheathed two or less times.No other steps or devices were used to open the pipeline.After repeated attempts, it was suspected that both the pipeline and the phenom 27 microcatheter were damaged so the devices were both removed.It was noted there had been resistance at the distal end of the catheter during the procedure as well.Both the pipeline and the phenom were replaced and two pipelines were ultimately implanted telescoping successfully to complete the procedure.There was no patient injury associated with this event.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 231796188); 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.
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 that resistance occurred when the stent was delivered to the mid-to-distal segment of the catheter.There were no damages observed on the pipeline push wire or catheter.

• 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: 24597952
• Report Number: 2029214-2026-00421
• Device Sequence Number: 9561035
• Product Code: OUT
• UDI-Device Identifier: 00763000284572
• UDI-Public: (01)00763000284572(17)280618(10)D046701
• 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,Followup,Followup
• Report Date (Section B): 06/17/2026

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: PED2-450-35
• Device Catalogue Number: PED2-450-35
• Device Lot Number: D046701
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/23/2026; 05/19/2026; 06/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/09/2026; 05/18/2026; 06/16/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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: 60 YR
• Patient Sex: Female