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

Model Number	PED2-500-16
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a pipeline flex with shield stent that failed to open at the distal end and was stuck in the phenom 27 microcatheter during retrieval.The patient was undergoing a procedure via right femoral access for flow diverter treatment of an internal carotid artery (ica) posterior communicating artery (pcom) aneurysm.The aneurysm max diameter was 6.3mm and the neck diameter was 4.4mm.The distal landing zone was 3.8mm; the proximal landing zone was 5.3mm.Patient's vessel tortuosity was normal.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).After access was established and the phenom 27 microcatheter was delivered in place, the pipeline stent was delivered.Once the pipeline was positioned, withdrawal of the microcatheter was initiated to start pipeline deployment.However, the pipeline distal end could not be opened despite repeated attempt to retrieve and redeploy.When retrieving the pipeline, it was stuck within the microcatheter.Both devices were replaced to complete the procedure successfully.There was no harm or injury to the patient.
Additional Manufacturer Narrative
Continuation of d10: product id: fg15150-0615-1s (231605090); 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
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 reporting that there were no causes or contributing factors for the pipeline failure to open and resistance during retrieval identified.The pipeline has not been placed in a vessel bend when it failed to open.The additional steps and/or other devices used to open the pipeline was, "attempted to retrieve and redeploy, as well as to change the deployment technique, all failed to open it." there was no damage observed to the pipeline or phenom after the removal.

• 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: 24531383
• Report Number: 2029214-2026-00377
• Device Sequence Number: 10372178
• Product Code: OUT
• UDI-Device Identifier: 00763000449544
• UDI-Public: (01)00763000449544(17)280919(10)D066713
• 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): 05/11/2026

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: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: D066713
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/16/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2025
• 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