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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Hearing Impairment (1881); Failure of Implant (1924); Stenosis (2263)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that a patient treated with two ped2 pipelines and phenom27 catheter had complication.Patient reports fatigue since procedure at 30-day follow up.Able to perform short periods of activity but needs frequent rest.Endorses increased heart rate with activity.No actions were taken.The event is resolving.The event was possibly related to study procedure.No actions were taken to resolve the fatigue.Baseline aneurysm characteristics: side (hemisphere): left.Segment of ica: c4.Location of aneurysm in vessel: other.Other specify: communicating.Aneurysm morphology: fusiform.Maximum aneurysm diameter: 4.8mm.Aneurysm dome height: 2.2mm.Aneurysm dome width: 3.9mm.Aneurysm neck size: 4.1mm.Parent artery diameter distal to aneurysm: 4mm.Parent artery diameter proximal to aneurysm: 4.5mm.Additional information received reported source document review found that the patient experienced post-operative headache.Small residual are of uncovered aneurysm neck was also noted.However, it was reported that: "control angiography following embolization demonstrated good wall apposition, no in-stent stenosis or thrombosis, and contrast stagnation within the aneurysm sac." additional information received clarified that there was improper landing of the ped2-475-14 device during the procedure, resulting in the neck not being fully covered.This was said to be a use error.As a result, a second pipeline was deployed to correct the issue.Both pipelines were successfully implanted will wall apposition achieved, and no flattening or twisting.It was reported that the patient reported experiencing headache at a follow-up on (b)(6) 2024.They were prescribed medrol from (b)(6) 2024, and the headaches recovered/resolved on (b)(6) 2024.No other treatment or hospitalization was required.The headaches were not the result of a device deficiency, and did not result in new or worsening neurological deficits.The site assessed the headaches as possibly related to the procedure not related to the disease under study, devices, or antiplatelet medication.
Additional Manufacturer Narrative
A2: date of birth is month/year valid.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
Additionalinformation received reported use error.Improper landing of device, resulting in neck not being fully covered.To correct, a second device was deployed.
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 there was no mention of friction or difficulty during delivery or positioning or of the tip of the catheter moving during deployment.
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 core-lab has reported ophthalmic branch stenosis of 76%-95%.The site has not reported any branch stenosis or adverse events.
Event or Problem Description
Additional information received reported that the patient experienced tinnitus at their 30-day follow-up visit on (b)(6) 2024 and were referred to an ent.No additional treatment or hospitalization for this issue was reported, and it was not the result of a device deficiency.The site assessed the tinnitus as not related to the device, procedure, or antiplatelet medication.The sponsor assessed the event as possibly related to the procedure and antiplatelet medication and could not exclude aspirin induced ototoxicity.The sponsor assessed the post-procedure headache as caused by the procedure and possibly related to the device.The sponsor assessed the fatigue at the 30-day follow-up as possibly related to the procedure and antiplatelet medication.It was reported that 180-day follow-up imaging showed ophthalmic branch stenosis of 76-95%.
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 regarding the adverse event of tinnitus.The clinical events committee assessed it as not related to the procedure and device, possibly related to antiplatelet therapy (apt).
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.

• 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: 21120758
• Report Number: 2029214-2025-00102
• Device Sequence Number: 7436510
• Product Code: OUT
• UDI-Device Identifier: 00763000284602
• UDI-Public: (01)00763000284602(17)261012(10)B639551
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/26/2025

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: PED2-475-14
• Device Catalogue Number: PED2-475-14
• Device Lot Number: B639551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 02/06/2025; 02/21/2025; 04/04/2025; 10/30/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/20/2025; 03/18/2025; 04/30/2025; 11/26/2025
• Date Device Manufactured: 10/13/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White