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

Model Number	PED2-350-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Headache (1880); Nausea (1970); Neuropathy (1983); Dizziness (2194); Numbness (2415); Paresthesia (4421); Suicidal Ideation (4429)
Date of Event	05/07/2024
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 a pipeline patent experienced a headache.The patient was being treated for a right ica c4 sidewall aneurysm with a saccular morphology.Aneurysm dimensions: maximum diameter 2.8 mm, dome height 1.4 mm, dome width 1.7 mm, neck size 2.8 mm.Parent artery diameter distal to aneurysm was 2.6 mm.Parent artery diameter proximal to aneurysm was 3.7 mm.No stasis was noted at the end of the procedure.Complete neck coverage was noted at the end of the procedure.Post implant aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.The access vessel was the femoral right.Rist was not used.The patient reported to emergency department with a headache, facial numbness dizziness right eye floaters nausea without emesis and paresthesia.The patient had a ct which showed no abnormalities.The patient left after the ct without being seen.The patient had a medical history of headaches, migraines, paresthesias and impaired cognition.The patient was being treated with zofran.The patient was also given 4 mg of ondansetron on (b)(6) 2024 subcutaneous. the adverse event (ae) did not result in the subject being hospitalized or a prolongation of an existing hospitalization.The ae was not treated with a surgical procedure.The patient was recovering/resolving.The ae was noted as possibly related to the procedure and disease under study.The ae resulted in a new or worsening of existing neurological deficits.Symptoms did not last for more than 24 hours.The ae did not result in a device deficiency.Side branches were not covered by pipeline device.No device flattening or twisting was noted.Wall apposition was achieved.The study device was successfully implanted in subject.Ancillary devices: guide catheter infinity 088, intracranial support catheter navien 058, microcatheter medtronic phenom 027, aristotle 014 additional information received reported the headache was possibly related to disease under study.Patient had migraines at baseline.Patient came to emergency department with headache, dizziness, right eye floater and nausea.Since patient came to emergency department for the headache management we may assume the patient experienced worsening of baseline symptoms.The device was successfully implanted and in use.Additional information received that site notified safety via email that rdc was not working properly and could not report sae."sae is suicidal ideation, severe, patient admitted to hospital after indicating that the patient's neuropathic pain has caused the patient to have suicidal ideation.Patient admitted after dsa for in-patient stay to be evaluated by pain management and psychiatry." there is no assessment for product/therapy/procedure relatedness made by the investigator, sponsor, or cec.The patient has a past medical history of subarachnoid hemorrhage, dizziness, encephalopathy, cold sores, migraine headaches, hyponatremia, subarachnoid hemorrhage due to ruptured anterior communicating artery a1 segment aneurysm, coiling of ruptured anterior communicating artery a1 segment aneurysm.It was reported the onset date of the neuropathic pain was (b)(6) 2024.A new hospitalization occurred on (b)(6) 2024 and ended on (b)(6) 2024.The adverse event resulted in treatment.Medication was administered for the adverse event: acetaminophen, baclofen, cyanocobalamin, gabapentin, hydromorphone, ketorolac, morphine, and prochlorperazine.The outcome date was (b)(6) 2024.The adverse event is possibly related to the disease under study.The patient has a history of neuropathic pain and paresthesia.The patient reported to the emergency department worsening neuropathic pain and was treated with pain regimen.Resolved with sequelae.Hospi talization was present.The neuropathic pain was not related to the study device or study procedure.Additional information was received that the suicidal ideation resulted in a new hospitalization from (b)(6) 2025.The patient had a psych consult and changes to pain medication.The outcome was recovered/resolved with sequelae on (b)(6) 2025.The event was assessed by the site as not related to the antiplatelet medication, retreatment procedure, rist catheter, study device, or study procedure.The sponsor assessed as serious due to the hospitalization.The event did not result in new or worsening of existing neurological deficits.The event did not result from a device deficiency.The event was possibly related to the disease under study.
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 it was confirmed this was not a worsening of baseline symptoms.
Event or Problem Description
Additional information received reported that cec adjudication result as not related to index procedure, device, or 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: 21345804
• Report Number: 2029214-2025-00348
• Device Sequence Number: 20768624
• Product Code: OUT
• UDI-Device Identifier: 00763000284145
• UDI-Public: 00763000284145
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

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: 02/08/2026
• Device Model Number: PED2-350-12
• Device Catalogue Number: PED2-350-12
• Device Lot Number: B617675
• 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: 02/02/2025
• Supplement Date Received by Manufacturer: 02/12/2025; 04/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/27/2025; 05/08/2025
• Date Device Manufactured: 09/05/2023
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 65 KG