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

Model Number	PED2-500-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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 a report that the pipeline flex with shield technology stent distal tip could not be opened after multiple attempts.The stent was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were reported with this event.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, saccular, c6 segment aneurysm with a max diameter of 5.8 mm and a 5.1 mm neck diameter.The landing zone arterial diameter was 4.97 mm distally and 5.01 mm proximally.It was noted the patient's vessel tortuosity was moderate.The angiographic result post procedure showed vascular patency.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices included: navien intracranial support catheter, phenom 27 microcatheter.
Additional Manufacturer Narrative
B5 updated with additional information received.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.There was no friction during delivery or positioning of the pipeline.Continuous saline flush was administered and maintained during the procedure as indicated in the ifu.There was no damage observed to the pipeline pushwire or the catheter.The pipeline had not been placed in a vessel bend when the failure to open occurred; it was positioned in a straight segment.Multiple attempts were made to retract and redeploy, swing, but maneuvers were not successful in opening the pipeline stent.
Additional Manufacturer Narrative
Product analysis ¿as found condition: the pipeline flex shield device was returned for analysis inside a sealed biohazard bag and inside a shipping box.¿damaged location details: the pipeline flex shield tip coil was observed to be stretched.The distal and proximal dps restraints and dps sleeves were intact, and no damage was noted.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube was stretched.No bends or kinks were found on the pusher wire.The braid was already detached from the pusher wire when it was returned; therefore, the distal and proximal ends could not be identified.One end of the braid was found closed and frayed, while the other end was open and frayed.The braid¿s middle section was open and damaged.No other anomalies were found.¿testing/analysis: n/a ¿conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ report could not be confirmed.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.However, one end of the braid was closed and frayed, while the other end was open and frayed.The braid¿s middle section was open and damaged.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 moderate and the pipeline had not been 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 hav e contributed to the failure to open.The braid can be damaged by over-manipulation, re-sheathing more than twice, or by deployment techniques.However, the cause of the braid damage could not be determined.The damage seen on the tip coil (stretched), braid (fra ying), and distal hypotube (stretched) indicates that high force was used.The damage may have occurred when the user attempted to advance or retrieve the pipeline flex shield device through the reported phenom 27 catheter.However, the cause of the 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: 23829549
• Report Number: 2029214-2025-02654
• Device Sequence Number: 8954452
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: (01)00763000284732(17)271016(10)B804132
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/24/2026

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: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B804132
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/06/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: Male