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

Model Number	PED2-400-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Muscle Weakness/Atrophy (1967); Dizziness (2194); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Ischemia Stroke (4418); Conjunctival Hemorrhage (4808)
Date of Event	10/15/2024
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 information that a patient treated with two ped2 pipelines had complications.Reported an episode of dizziness, confusion and weakness occurred that morning.She drank water and felt better.Provider suggested that she discontinue herbal supplements.The event resolved on (b)(6) 2024.Baseline aneurysm characteristics: side (hemisphere): left.Segment of internal carotid artery (ica): c6.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 4.7mm.Aneurysm dome height: 4.8mm.Aneurysm dome width: 4.7mm.Aneurysm neck size: 3.7mm.Parent artery diameter distal to aneurysm: 3.6mm.Parent artery diameter proximal to aneurysm: 3.7mm.Complete stasis post implant.Additional information received reported that the patient experienced fatigue and conjunctival hemorrhage.The patient presented to family medicine with complaints of conjunctival hemorrhage.The patient stated waking up with itchy eyes, proceeding with scratching and noticed blood in the left eye.Possibly related to apt.Post index and extubation, the patient had right hemiparesis due to stroke.Retreatment showed in-stent thrombus.Ptosis and extremity weakness was present at 180 follow up, secondary to stroke.The adverse event (ae) did not result from a device deficiency.Rist was not used.The access vessel was the femoral right.The pipeline was successfully implanted in the patient.Wall apposition was achieved.The side branches were covered by the pipeline (opthalmic).No device flattening or twisting was reported.Ancillary devices: primary guide catheter used cath armadillo selectflex 27cm, primary microcatheter used cath neur select ber 5fr 130cm, primary guide catheter used 7fr 072 armadillo, primary intracranial support catheter neuron select berenstein 5 fr 130cm, primary microcatheter 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 received reported that the patient was recovering/resolving.Core-lab had reported ophthalmic branch stenosis is angiographically occluded.The subject has had a stroke and device thrombosis as reported adverse events (aes).
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 the patient was still recovering.It was unknown if the device was prepared as indicated in the ifu (inspection, hydration, etc.).The cause of the stroke was not determined.The site stated relatedness as causal to procedure.
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 the event was possibly related to the procedure and antiplatelet treatment, and causal to the device.
Event or Problem Description
Additional information received that the adverse event resolved on (b)(6) 2025.
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
H6: patient coding corrected 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.
Additional Manufacturer Narrative
H6: patient coding corrected 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
Additional information received that the corelab review of 1-year follow up dsa imaging on (b)(6) 2025, reported the ophthalmic branch artery was angiographically occluded.There was no parent artery stenosis and complete occlusion of aneurysm.No symptoms were reported in association with this finding.Site reports principal investigator agreed with findings of occlusion of the ophthalmic artery.Patient was asymptomatic and was having no serious side effects.The adverse event (ae) did not result in any treatment action, hospitalization or prolongation of an existing hospitalization, treat ment of another manner, treatment with blood transfusion, treatment with percutaneous intervention, or surgical procedure.Outcome status was noted as not recovered/not resolved.The ae did not result in any diagnostic procedure or testing.The ae occurred post-procedure, was possibly related to the disease under study, did not result in new or worsening of existing neurological deficits, and did not result from a device deficiency.There was no congenital anomaly, death, disability, hospitalization, life threatening condition, or medical intervention.The physician assessment for product/therapy/procedure relatedness to the ophthalmic branch artery occlusion indicated causal relationship to the study procedure, possibly related to the antiplatelet medication or study device, and not related to the retreatment procedure or rist catheter.

• 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: 21833727
• Report Number: 2029214-2025-00979
• Device Sequence Number: 19889627
• Product Code: OUT
• UDI-Device Identifier: 00763000284367
• UDI-Public: (01)00763000284367(17)261220(10)B672913
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PED2-400-20
• Device Catalogue Number: PED2-400-20
• Device Lot Number: B672913
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 04/21/2025; 05/18/2025; 09/09/2025; 11/04/2025; 11/04/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/07/2025; 06/03/2025; 10/07/2025; 11/26/2025; 11/26/2025
• Date Device Manufactured: 12/21/2023
• 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: Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White