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

Model Number	PED2-450-20
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
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
Medtronic received information regarding a pipeline shield that failed to open.The patient was undergoing a procedure for flow diverter treatment of a left internal carotid artery (l-ica) posterior communicating segment (pcom) unruptured saccular aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 4mm.The distal landing zone was 5mm; the proximal landing zone was 10mm.Dual antiplatelet treatment (dapt) was administered.Patient's vessel tortuosity was normal.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).The microc atheter was delivered to the m2 segment and the pipeline was delivered; deployment was initiated in the m1 horizontal segment.When approximately 15mm of pipeline stent was deployed, the tip end of the stent did not open.The surgeon attempted to open the stent by pushing it but it still did not open.The pipeline was retrieved and the surgeon attempted to fold and manipulate the sheath using the microcatheter and reattempted deployment but it still failed to open and the tip end of the stent was found damaged in a conical shape.The pipeline was then replaced to complete the procedure.There was no harm or injury to the patient associated with this event.Post procedure angiography results showed the aneurysm was treated with the replacement pipeline implanted.Ancillary devices: ruikangtong 5f 115cm intracranial support catheter, neuromax 0.099 long sheath, phenom 27 microcatheter, asahi 0.014 guidewire.
Event or Problem Description
Additional information was received that the distal section of the pipeline failed to open.The pipeline was not placed in a vessel bend when it failed to open.It was in the straight segment of the middle cerebral artery.After attempting to retrieve and deploy the stent to a sufficient length, and performing a pushing stent operation, the stent still failed to open.The pipeline was resheathed 2 times.Regarding the cause of the failure to open, it was noted that considering that the tip protection sheath did not flip over, causing the stent to not open, the stent was retrieved and re-deployed, but it still did not open, suggesting that the tip end was damaged.
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.
Additional Manufacturer Narrative
H3: product analysis ¿as found condition: the pipeline flex shield braid was returned for analysis inside an open pipeline flex shield inner pouch, inside a sealed biohazard bag, and inside a shipping box.The pipeline flex shield pusher wire was not returned.¿damaged location details: the pipeline flex shield braid was already detached from the pusher wire when it was returned; therefore, the distal and proximal ends could not be identified.Both braid ends were open and frayed.The braid¿s middle section was fully open without damage.No other anomalies were found.¿conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ report could not be confirmed, as both ends of the returned pipeline flex shield braid were open and frayed.However, the cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity, the user deploying the braid in the vessel bend, and a damaged braid.In this event, the customer reported that the vessel tortuosity was normal, and the pipeline was not placed in a vessel bend, ruling out vessel tortuosity and the user deploying the braid in the vessel bend as possible causes.Therefore, a damaged braid could have contributed to the failure to open.The braid can be damaged due to over-manipulation, deployment techniques, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing against resistance.However, the cause of the braid damage could not be determined.The cause of the reported event could not be determined.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.

• 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: 23728700
• Report Number: 2029214-2025-02545
• Device Sequence Number: 13064197
• Product Code: OUT
• UDI-Device Identifier: 00763000449384
• UDI-Public: (01)00763000449384(17)280609(10)D044541
• 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: 2025
• Device Explanted Year: 2025
• 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): 02/04/2026

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: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: D044541
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/30/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 72 KG