MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG15150-0615-1S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Paresis (1998); Ischemia Stroke (4418); Embolism/Embolus (4438); Hypokalemia (4825)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B5 updated based on additional information received.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 only one rist radial access catheter was known to be used in the index procedure which was the device with lot 17957-01.The site adjudicated assessment of the event to indicate that the event had a causal relationship to the procedure and possibly related to the antiplatelet medical, navien catheter and/or phenom 27 microcatheter but was not considered by the site to be related to the implanted pipeline.The study sponsor assessment concludes event was possibly related to the procedure, pipeline vantage, and/or antiplatelet medication.
Event or Problem Description
Medtronic received information that a patient treated with a ped3 pipeline, two rist radial access catheters, navien support catheter, and phenom 27 catheter had complications.Monoparesis of the left arm partially regressing during hospitalization.Paresis of the left upper limb, without ischemia demonstrated on the follow-up mri (b)(6) 2022, but with a light effraction of the blood-brain barrier in a frontal sulcus explaining the symptoms.No actions were taken.The event resolved on 2022-jul-25.The event had a causal relationship to the procedure and possibly related to pipeline and dual antiplatelet therapy.Additional information received reported intracranial hemorrhage and post-op hypokalemia with an nacl infusion.Additional information received reported that the patient's monoparesis of the left arm was related to some ischemic spots in the right sylvan region, partially regressing during hospitalization.It was noted the patient experienced a stroke.The site updated their assessment to possibly related to antiplatelet medication and possibly related to the navien catheter.Baseline aneurysm characteristics: side (hemisphere): right.Location (vessel): posterior communicating artery.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 9.8mm.Aneurysm dome height: 9.8mm.Aneurysm dome width: 7.9mm.Aneurysm neck size: 3.8mm.Parent artery diameter distal to aneurysm: 3.5mm.Parent artery diameter proximal to aneurysm: 3.5mm.
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.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
Per the clinical event committee (cec), assessment of the stroke event was adjudicated on (b)(6) 2025 and updated conclusion that the stroke event had a causal relationship to the procedure and possibly related to the pipeline device but was not related to any ancillary device or antiplatelet medications.
Event or Problem Description
Additional information received reported the ischemia lesions and patient symptoms regressed partially during the patient's hospitalization.Ischemic lesions possibly related to emboli and possibly related to phenom 27 microcatheter.
Additional Manufacturer Narrative
B5 updated with additional information received d3, d4 device information updated based on available information received.H6 patient coding updated based on additional information received.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: PHENOM CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23103297
• Report Number: 2029214-2025-02058
• Device Sequence Number: 15878657
• Product Code: QJP
• UDI-Device Identifier: 00847536041868
• UDI-Public: (01)00847536041868(17)240930(10)OC21-042
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2025

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 Expiration Date: 09/30/2024
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: OC21-042
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/24/2025; 11/21/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/31/2025; 12/01/2025
• Date Device Manufactured: 10/20/2021
• 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: Other
• Patient Sex: Female
• Patient Weight: 61 KG