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

Model Number	PED2-450-25
Medical Device Problem Codes	Unintended Ejection (1234); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a pipeline was detached during the second retrieval and could not be used.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured ophthalmic artery aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 4 mm and neck diameter 5 mm.Landing zone (artery size): distal 12 mm and proximal 10 mm.The patient¿s vessel tortuosity was normal.Dapt (dual antiplatelet treatment) was administered (pru level 0).The angiographic result post procedure was normal.There were no patient symptoms or complications associated with this event.
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.
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 after detachment, the pipeline could not be implanted and was removed.The device was replaced to complete the procedure.The cause of the pipeline detachment was not determined.
Additional Manufacturer Narrative
Product analysis #821249947: ¿ equipment used: video inspection system (m-85519), camera (panasonic lumix dmc-zs5); ruler (m-83361) ¿ drawing(s) referenced: n/a ¿ as found condition: the pipeline flex shield braid was returned inside the inner pouch, biohazard bag, and shipping box.The pushwire was not returned.¿ visual inspection/damage location details: the braid's distal and proximal ends were found opened and frayed.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the returned device, the customer complaint was confirmed, as the pipeline flex shield braid was found to be detached from the pushwire.The braid's distal and proximal ends were found opened and frayed.The cause could not be determined.It is possible that the pipeline flex shield braid was deployed past the resheathing marker, causing the braid to come off from the resheathing pad during resheathing.Per our instructions for use: "the pipeline flex shield embolization device can be re-sheathed until the re-sheathing marker has reached the distal marker of the micro catheter." damage to the braid can occur due to resheathing more than 2 times, over-manipulation, deployment technique, advancing or retracting the delivery wire against resistance, or deploying/resheathing the braid 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: 21401057
• Report Number: 2029214-2025-00445
• Device Sequence Number: 9345776
• Product Code: OUT
• UDI-Device Identifier: 00763000284558
• UDI-Public: (01)00763000284558(17)261120(10)B658606
• 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: 2025
• Device Explanted 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,Followup,Followup
• Report Date (Section B): 06/22/2026

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: PED2-450-25
• Device Catalogue Number: PED2-450-25
• Device Lot Number: B658606
• 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: 02/16/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 04/10/2025; 06/15/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/20/2025; 04/29/2025; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Patient Sex: Female