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

Model Number	PED2-450-12
Medical Device Problem Codes	Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263); Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the patient had 6-month imaging done at day 180.Crf noted class 3 stenosis and complete wall apposition not achieved.Site did a retreatment on subject's residual aneurysm at 6 months.There was no assessment for product/therapy/procedure relatedness made by the investigator, sponsor, or cec.See manufacturer report 2029214-2024-00166 for related device.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H6 codes have been updated.*pli20 no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless a dditional information received makes the pli reportable.Due to gch functionality, the complaint flag cannot be flipped to 'no' as a regulatory report exists in this pe* medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received reporting the patient's prolonged hospitalization was due to retreatment.Medtronic received a report that the patient underwent target treated aneurysm retreatment onset date 2023-11-30.The retreatment resulted in new hospitalization (icu) from 2023-11-30 to 2023-12-01.A second pipeline device (lot b561271) was placed into original.The aneurysm was still filling and the patient was experiencing bruising due to dual antiplatelet therapy (dapt).The treating physician decided to retreat the aneurysm so that they could stop dapt.This event did not lead to congenital anomaly, death, disability, or medical intervention and was not considered life-threatening per the site.The patient recovered and the issue resolved.The patient was undergoing surgery for treatment of a saccular, left internal carotid artery (ica) c7 side branch aneurysm with a max diameter of 7mm and a 4mm neck diameter.The aneurysm dome height was 7mm and width 4mm.Parent artery diameter distal to aneurysm was 3.8mm.Parent artery diameter proximal to aneurysm was 4.1mm.There was no stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.Post implant aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.Aneurysm symptoms included altered mental status, localized headache, migraines, nausea/vomiting, and photophobia (sensitivity to light.) *pli20 no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless a dditional information received makes the pli reportable.Due to gch functionality, the complaint flag cannot be flipped to 'no' as a regulatory report exists in this pe.

• 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 ; +1(763)526-5677
• MDR Report Key: 18583905
• Report Number: 2029214-2024-00167
• Device Sequence Number: 20894668
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: (01)00763000284503(17)260508(10)B561271
• 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: 2023
• 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): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2026
• Device Model Number: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B561271
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 01/30/2024; 08/31/2026
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/16/2024; 09/29/2026
• Date Device Manufactured: 05/09/2023
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 218 LB