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	10/25/2024
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 stent that failed to open at the distal end.The patient was undergoing a procedure for embolization of a c6 segment lateral wall unruptured saccular aneurysm.The aneurysm max diameter was 5.96mm and the neck diameter was 4.83mm.The distal landing zone was 3.75mm and proximal landing zone was 5.22mm.Vessel tortuosity was moderate.It was reported that the pipeline and all accessory device were prepared per the instructions for use (ifu).When less than 50% of the pipeline stent was deployed, the distal tip could not be opened.The pipeline was not positioned in a bend.The pipeline was resheathed less than 2 times; no other steps or devices were used to open the pipeline.It was resheathed and removed with the microcatheter.The pipeline was then replaced to complete the procedure successfully.There was no harm or injury to the patient.Post-procedure angiography showed normal blood flow in the vessel.
Additional Manufacturer Narrative
H3: product analysis #707170091:equipment used: video inspection system (m-81805), camera (panasonic lumix dmc-zs5) as found condition: the pipeline flex device was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were found to be intact, with no signs of damage.No defects were found on the re-sheathing marker or re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation and damage.The braid¿s distal end was not open and damaged, while the proximal end was opened and frayed.No damage was noted on the pushwire.No other anomalies were noted.Conclusion: based on the reported information and device analysis, the customer¿s complaint of ¿failure/incomplete to open at distal¿ was confirmed, as the returned pipeline flex braid¿s distal end was not opened and damaged.Additionally, the braid¿s proximal end was opened and frayed.However, the cause of the failure to open could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, and a damaged braid.The customer reported moderate vessel tortuosity, and the braid was not placed in the vessel bend, ruling out vessel tortuosity, and the user deploying the braid in the vessel bend as potential causes.A damaged braid may have contributed to the failure to open complaint.The braid can be damaged due to over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/re-sheathing delivery wire against resistance.However, the cause of the braid damage 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.
Additional Manufacturer Narrative
Correction: h6 device evaluation result and conclusion codes corrected to reflect analysis findings/conclusion.H3.Product analysis: equipment used: video inspection system (m-81805), camera (panasonic lumix dmc-zs5) as found condition: the pipeline flex device was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were found to be intact, with no signs of damage.No defects were found on the re-sheathing marker or re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation and damage.The braid¿s distal end was not open and damaged, while the proximal end was opened and frayed.No damage was noted on the pushwire.No other anomalies were noted.Conclusion: based on the reported information and device analysis, the customer¿s complaint of ¿failure/incomplete to open at distal¿ was confirmed, as the returned pipeline flex braid¿s distal end was not opened and damaged.Additionally, the braid¿s proximal end was opened and frayed.However, the cause of the failure to open could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, and a damaged braid.The customer reported moderate vessel tortuosity, and the braid was not placed in the vessel bend, ruling out vessel tortuosity, and the user deploying the braid in the vessel bend as potential causes.A damaged braid may have contributed to the failure to open complaint.The braid can be damaged due to over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/re-sheathing delivery wire against resistance.However, the cause of the braid damage 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.
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 reporte there was no friction or resistace during delivery or positioning of the pipeline.

• 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: 20608794
• Report Number: 2029214-2024-02068
• Device Sequence Number: 17976067
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: 00763000284732
• 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: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/04/2025

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 Model Number: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B671041
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 12/29/2024; 03/04/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/14/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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 Age: 37 YR
• Patient Sex: Female