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	Unintended Ejection (1234); Structural Problem (2506); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2024
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
It was reported that during a procedure involving a pipeline embolization device, several complications occurred.The patient experienced a carotid dissection and an ischemic stroke, with the dissection located in the left internal carotid artery (lica).A coronary stent was initially used for radial force but was damaged (mangled) when attempting to reaccess the vessel distally.The device reportedly came off the delivery wire prematurely, leading to the placement of an additional pipeline.Migration of the device proximally was noted, necessitating the placement of another device for better coverage.Both pipelines were confirmed to be patent.The procedure was performed for a cervical carotid dissection, which was an off-label use of the device.The angiographic result post-procedure indicated that an additional pipeline was placed for better coverage.
Additional Manufacturer Narrative
H3: product analysis as found condition: the pushwire was returned inside the inner pouch, outer carton, biohazard bag and shipping box.There was no braid returned with the pushwire.Visual inspection/damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation.The braid appeared to be detached from the pushwire.No bend was found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker, or proximal bumper.No other anomalies were observed.Conclusion: based on the returned device, the customer complaint was confirmed, as the pushwire was returned without the braid.However, the cause could not be determined.Possible causes include resistance during delivery, over-manipulation, pushwire was torqued/pulled back during insertion or advancing braid inside microcatheter, and/or resheathing device more than 2 times.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: ¿ equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) ¿ as found condition: the pushwire was returned inside the inner pouch, outer carton, biohazard bag and shipping box.There was no braid returned with the pushwire.¿ visual inspection/damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation.The braid appeared to be detached from the pushwire.No bend was found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker, or proximal bumper.No other anomalies were observed.¿ conclusion: based on the returned device, the customer complaint was confirmed, as the pushwire was returned without the braid.However, the cause could not be determined.Possible causes include resistance during delivery, over-manipulation, pushwire was torqued/pulled back during insertion or advancing braid inside microcatheter, and/or resheathing device more than 2 times.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 clarification of the event.After dissection was observed by the surgeon, it was decided to place a rigid coronary stent.Re-access of the coronary stent causes the coronary stent to become mangled beyond repair.The decision was then made to try to reconstruct the vessel as well as possible using pipeline flex.During delivery, the first pipeline flex deployed prematurely and foreshortened within the damaged original coronary stent so the second pipeline was implanted with no issue and both implanted pipelines were patent by the end of the procedure.The damage to the pipeline was due to snagging and other interference from the damaged coronary stent and it was considered likely the coronary stent also played a role in the premature deployment of the first pipeline.The pipeline foreshortening or migration was also considered to be due to difficult apposition because of the presence of the damaged coronary stent.At the end of the procedure, two pipeline flex devices were ultimately implanted at the intended treatment location and both were patent with no apparent damage.

• 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: 21092228
• Report Number: 2029214-2025-00055
• Device Sequence Number: 8657043
• Product Code: OUT
• UDI-Device Identifier: 00763000284756
• UDI-Public: 00763000284756
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2026
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B598559
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 03/26/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/18/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male