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

Model Number	PED2-425-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Headache (1880); Pain (1994); Vasoconstriction (2126); Stenosis (2263)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a patient was diagnosed with bacterial sinusitis post procedure.The patient had sharp headache pain when coughing or sneezing.Pain sharp and gone when done coughing or sneezing.The event did not result in new or worsening of existing neurological deficits and did not result from a device deficiency.The even resulted in medication- amoxicillin-clavulanate 875-125mg bid x7days.There was no hospitalization.The outcome was recovering/resolving.The patient was undergoing surgery for treatment of a saccular, sidewall aneurysm of the left internal carotid artery (c5) with a max diameter of 15.6mm and a 7mm neck diameter.Aneurysm dome height was 11.7mm and width was 13.3mm.Parent artery diameter distal to aneurysm was 3.9mm and proximal to aneurysm was 4.8mm.There was complete stasis and neck coverage at the end of the procedure.Raymond and roy at the end of the procedure was class 3.The study device was successfully implanted with wall apposition achieved and no side branches covered.There was no device flattening or twisting.Ancillary devices include a rist radial access 071, phenom plus, and phenom 027 catheter.
Additional Manufacturer Narrative
A2: patient date of birth is approximate.Year is confirmed valid.Continuation of d10: product id unk-nv-rist (unknown); implant date n/a; explant date n/a, product id (unknown); product id (unknown).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 was received reporting the cause of the event was not determined.This information has been confirmed with the physician.Additional information was received reporting the adverse event (ae) was not related to the disease under study.The site assessed this event as not related to antiplatelet medication or device and possibly related to the study 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 there was an unreported event of vasospasm during 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 adjudicated as possibly related to procedure.Onset date was corrected to 2024-dec-16.The event resolved on 2025-jan-16.
Additional Manufacturer Narrative
B5 updated with 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 core lab image review of 1-year follow-up digital subtraction angiographic (dsa) imaging on (b)(6) 2026 showed 76-95% stenosis of the posterior communicating (pcom) artery branch.The site reported no side branches were covered by the implanted pipeline at the index procedure.There were no associated patient symptoms or additional action taken associated.

• 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: 21273185
• Report Number: 2029214-2025-00249
• Device Sequence Number: 8156816
• Product Code: OUT
• UDI-Device Identifier: 00763000284442
• UDI-Public: (01)00763000284442(17)260419(10)B551665
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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 Expiration Date: 04/19/2026
• Device Model Number: PED2-425-18
• Device Catalogue Number: PED2-425-18
• Device Lot Number: B551665
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 01/30/2025; 02/18/2025; 06/05/2025; 02/03/2026
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/14/2025; 03/11/2025; 06/23/2025; 02/10/2026
• Date Device Manufactured: 04/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 89 KG