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

Model Number	PED2-475-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: ped2-500-14 (b709119).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
It was reported that during a neurovascular flow diversion procedure involving the pipeline embolization device, the distal end of the pipeline device failed to open on two occasions.The device was positioned in a bend at the middle section for both devices.More than 50% had been deployed when the devices failed to open.The device was resheathed more than two times in both instances and subsequently removed from the patient each time.The doctor tried "all the tricks" to get the device open and it would not work.The procedure was completed by implanting a surpass flow diverter, which resulted in a satisfactory angiographic outcome.The aneurysm was located in the internal carotid artery, unruptured, with a saccular morphology, a maximum diameter of 5.3 millimeters, and a neck diameter of 2.3 millimeters.The landing zone measured 3.9 millimeters distally and 4.7 millimeters proximally, with moderate vessel tortuosity.
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 reported that the cause of the event was unknown.The distal end would not open, but they did not know why.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): equipment used: video inspection system (m-81805), camera (panasonic lumix dmc-zs5) as found condition: the pipeline flex shield device was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex shield¿s 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 and proximal ends were opened and frayed.The braid¿s middle part was also opened.No defects were found on the pushwire.No other anomalies were found.Conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ complaint was not confirmed, as the returned pipeline flex shield braid¿s distal end was opened and frayed, as its proximal end.However, the cause of the failure could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, and a damaged braid.In this event, the customer reported moderate vessel tortuosity, ruling out vessel tortuosity as a possible cause.The user deploying the braid in the vessel bend and a damaged braid may have contributed to the failure to open complaint.The braid can be damaged due to over-manipulation, re-sheathing more than two times, deployment technique, delivery/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.

• 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: 20872613
• Report Number: 2029214-2024-02255
• Device Sequence Number: 18350673
• Product Code: OUT
• UDI-Device Identifier: 00763000284602
• UDI-Public: 00763000284602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 01/11/2025
• Device Model Number: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: B321852
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/23/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 86 KG