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

Model Number	PED2-300-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a pipeline flex shield pushwire broke during removal of the delivery system post stent deployment.The patient was undergoing surgery for treatment of a ruptured, right internal carotid artery (ica) aneurysm with a max diameter of 2 mm and a 2 mm neck diameter.The landing zone artery diameter was 3.00 mm distally and 4.5 mm proximally.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered.Angiographic result post procedure showed no complication related to the event.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).It was reported that the pushwire broke proximal to the re-sheathing pad, when removing the delivery system post deployment.The physician was able to snare the broken segment of the pushwire and remove it from the patient after multiple attempts using a snare/retrieval device.Pushwire damage was noted as a break in the distal section of the pushwire.There was no friction or difficulty reported.The device was successfully implanted in the patient.No patient symptoms or complications were 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.
Event or Problem Description
Additional information was received.The cause of the pushwire break was undetermined.
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
Product analysis: ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; and within a plastic bio-pouch.The pipeline flex shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: no bend was observed on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The pushwire appeared to be broken at distal hypotube and the remaining segment was not returned for analysis.Therefore, any contributing factors could not be assessed.No other anomalies were observed.¿testing/analysis: the broken end was sent out for sem (scanning electron microscopy) analysis.¿ conclusion: based on the analysis findings, the pipeline flex shield was confirmed to have pushwire break/separation as the pushwire appeared to be broken at distal hypotube.Per the sem result, ¿the broken end exhibit features consistent with a fatigue failure.¿ possible causes of failure: patient vessel tortuosity, resistance/high force delivery, pushwire damage, hypotube stretched, catheter damage, and user resheaths more than 2 times.It was noted the patient's vessel tortuosity was normal.Which eliminates this factor out as potential causes.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: 22680301
• Report Number: 2029214-2025-01733
• Device Sequence Number: 13129816
• Product Code: OUT
• UDI-Device Identifier: 00763000283957
• UDI-Public: (01)00763000283957(17)261101(10)B649167
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/06/2025

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: PED2-300-10
• Device Catalogue Number: PED2-300-10
• Device Lot Number: B649167
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 10/06/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/28/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 65 YR
• Patient Sex: Female