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

Model Number	PED2-400-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Pain (1994); Blurred Vision (2137); Visual Disturbances (2140); Stenosis (2263); Numbness (2415); Obstruction/Occlusion (2422); Nervous System Injury (2689); Ischemia Stroke (4418); Diplopia/Double Vision (4802)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
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
Medtronic received a report that there was cerebral infarction with onset date of 2025-06-13.This adverse event (ae) did not result in any treatment, hospitalization, blood transfusion, percutaneous intervention, or surgical procedure.The outcome status is not r ecovered/not resolved.Ae occurred post-procedure.Ae possible related to the disease under study.Ae resulted in a new or worsening of existing neurological deficits, symptoms lasted more than 24 hours.Ae did not result from a device deficiency.Patient "experiencing" new left-hand numbness after 1 year digital subtraction angiography (dsa) on (b)(6) 2024.Magnetic resonance imaging (mri) on (b)(6) 2025 showed multiple right sided early subacute infarcts.The site assessed this event as not leading to congenital anomaly, death, disability, hospitalization, or medical intervention.It was considered life-threatening.The site assessed this event as not related to antiplatelet medication, device, or procedure.Sponsor assessment was "yes".The patient was undergoing surgery for treatment of a saccular, left c5 internal carotid artery (ica) sidewall aneurysm with a max diameter of 5.6 mm and a 4.8 mm neck diameter.The aneurysm dome height was 4.8 mm, and neck was 5.6 mm.Parent artery diameter distal to aneurysm: 3.8mm.Parent artery diameter proximal to aneurysm: 3.8mm.There was complete stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.The aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.Ancillary devices include an axs infinity ls, navien 058, medtronic phenom 027.
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 reporting that there was no treatment done to resolve the numbness/infarction.Sponsor has assessed as possibly related to device, disease under study and antiplatelet medication.The cause of the numbness/infarction was not determined.Additional information was received reporting that core lab has reported at 1 year imaging on (b)(6) 2025 that branches arising from the parent artery have a degree of stenosis: posterior communicating (pcom) artery, angiographically occluded.It was unknown if any impact to the patient or any if additional medical intervention was required to prevent permanent injury or impairment.The patient's medical history includes: medical / surgical condition: migraine; start date unk repair of ankle fracture; start date unk lithotripsy x2; start date unk selective catheterization ea 1st order thoracic/brch/cphlc; start date (b)(6) 2024 arthroscopy hip w/labral repair right; start date unk kidney stone removal; start date unk selective catheter carotid/innominate art angio; start date (b)(6) 2024 selective catheter intrnl cartoid art antio; start date (b)(6) 2024 selective catheter vertebral art angio; start date (b)(6) 2024 xa cervicocerebral arteriogram; start date (b)(6) 2024.
Additional Manufacturer Narrative
A2: patient's year of birth is valid, date entered reflects the first date of the birth year.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 reporting that national institutes of health stroke scale (nihss) score reported at 1 year visit ((b)(6)2025) is 1, however nihss score pre-procedure was 0.A query has been issued to the site to clarify reason for change in score.There was no assessment for product/therapy/procedure relatedness made by the investigator, sponsor, or clinical events committee (cec).The cause of the stenosis/occlusion was not determined.The resolution of the stenosis/occlusion is unknown and there are no additional actions reported.
Event or Problem Description
Additional information received reported the decline in nihss score was due to adverse event of cerebral infarction with start date of 13-jun-2025.No action or interventions were reported to resolve the change in score.The cerebral infarction is not resolved.
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
Cec adjudicated the cerebral infarction as caused by the procedure and not related to the device or antiplatelet therapy.The site updated their assessment to caused by the procedure.
Additional Manufacturer Narrative
H6: patient coding corrected/updated based on all available events.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
Medtronic received information that a patient treated with a ped2 pipeline stent, phenom 27 catheter, and navien catheter had complications.Patient reports increased headaches since procedure.Patient received course of steroids which helped; patient now back to baseline levels of migraines.It resolved on (b)(6) 2024.Patient reports increased fatigue since procedure; reports being unable to return to work and feeling sluggish during the day.The fatigue is not resolved.Patient describes fuzzy smoke in left eye and blurriness that improves with glasses.Saw neuro-ophtho for evaluation that was negative.No actions were taken.The event was possibly related to the procedure.Baseline aneurysm characteristics: side (hemisphere): left.Segment of internal carotid artery (ica): c5.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 5.6mm.Aneurysm dome height: 4.8mm.Aneurysm dome width: 5.6mm.Aneurysm neck size: 4.8mm.Parent artery diameter distal to aneurysm: 3.8mm.Parent artery diameter proximal to aneurysm: 3.8mm.Additional information received reported source states, initially experienced double vision.Black float/smoke in the superior part of her left eye.Describes episodes of visual disturbance.Mri susceptibility artifact.No specific action for fatigue was reported.Patient has medical history of migraine headaches as well.For the headache episode a course of steroid was given.Patient was started on ajovy.No specific cause for events reported.Event date updated noting onset of headache was (b)(6) 2024.No other new information.Additional information received reported cec adjudication result: possible to index procedure and apt.Not related to the device.Medtronic received information that a patient treated with a ped2 pipeline, phenom 27 catheter, and navien catheter had complication s.Patient reported pain at access site from (b)(6) 2024 through (b)(6) 2024.The event resolved on (b)(6) 2024.The event had a causal relationship to the procedure.Baseline aneurysm characteristics: side (hemisphere): left.Segment of internal carotid artery (ica): c5.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 5.6mm.Aneurysm dome height: 4.8mm.Aneurysm dome width: 5.6mm.Aneurysm neck size: 4.8mm.Parent artery diameter distal to aneurysm: 3.8mm.Parent artery diameter proximal to aneurysm: 3.8mm.Additional information was received.Date of implant was (b)(6) 2024.Site updated 180 day mrs to 2 ((b)(6) 2024).Site reports mrs 3 at 1 year follow-up visit on (b)(6) 2025.A query has been issued to clarify the change in mrs.Additional information received reported that the patient symptoms or complications resulting in the designation of mrs 3 at the 1 year follow up visit included worsening of headaches, visual disturbance, and fatigue worsened since the previous visit.No actions or interventions were reported.The existing visual disturbance and fatigue aes are site-reported as not recovered / not resolved.The headache event is site-reported as recovered / resolved on (b)(6) 2024; site has been queried to determine if the existing headache ae is ongoing, or if it is a new ae.

• 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: 22329459
• Report Number: 2029214-2025-01462
• Device Sequence Number: 12837189
• Product Code: OUT
• UDI-Device Identifier: 00763000284329
• UDI-Public: (01)00763000284329(17)270328(10)B711459
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PED2-400-12
• Device Catalogue Number: PED2-400-12
• Device Lot Number: B711459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 07/14/2025; 08/05/2025; 10/19/2025; 12/11/2025; 09/01/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/04/2025; 08/28/2025; 10/19/2025; 01/09/2026; 09/30/2026
• Date Device Manufactured: 03/28/2024
• 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: Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 140 LB