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

Model Number	PED2-500-35
Medical Device Problem Codes	Collapse (1099); Positioning Failure (1158); Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is not known.Information has been requested.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 flex with shield that had very difficult deployment.The pipeline opened/deployed prematurely, was difficult to position, and required adjustive assist to open properly.The patient was undergoing a procedure to treat a common carotid fistula (ccf) that was believed to have been caused by a recent motorcycle accident.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline was being used off-label to rebuild the ica in the case of ccf.Coils were used to embolize the venous side of the fistula.The pipeline and all accessory devices were prepared per the instructions for use (ifu).Partway through deployment, the pipeline slipped off of the proximal pad.Retrieval of the system was attempted but the pipeline just started deploying further.The physician attempted to retrieve the pipeline with the navien intermediate catheter but could not so both the microcatheter and navien catheter were pulled back to deliver the pipeline stent.A couple of sections of the pipeline appeared pinched/unopened but they were able to pass the microcatheter through the pipeline to open the stent a bit, then balloon angioplasty was performed to open the pipeline more completely.Though the deployment was very difficult, it was ultimately successful.There was no harm or injury to the patient.Ancillary device: navien intracranial support catheter.
Event or Problem Description
Additional information received reported vessel tortuosity was normal.The pipeline was slow to open distally.Physician reported this was not unexpected given the size of the device.The catheter was a phenom27 catheter.The pipeline was implanted at the intended location.It shifted proximally slightly during recapture attempt but not significantly.The tip of the microcatheter has to move to deploy the device.A distal portion and a middle portion did not open.The pipeline distal deployment was a straight segment.There was no issue with a navien catheter.
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.

• 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: 22797646
• Report Number: 2029214-2025-01819
• Device Sequence Number: 8512309
• Product Code: OUT
• UDI-Device Identifier: 00763000284756
• UDI-Public: (01)00763000284756(17)260705(10)B618844
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 09/05/2025

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 Expiration Date: 07/05/2026
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B618844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 09/19/2023
• 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 Sex: Unknown