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

Model Number	PED2-275-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cognitive Changes (2551); Ischemia Stroke (4418)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the patient was undergoing a procedure that involved a pipeline.Per site reported data, mri 24hrs post procedure reported presence of new infarction since last imaging.Site also reported an adverse event for abulia.For abulia, iv bolus normal saline was given.The adverse event resulted in a diagnostic cerebral angiogram.It was reported that following extubation, the patient followed commands 4/5 on left side and 3/5 on right side and able to raise right arm fully of the bed with a drift.Patient's voice was hoarse and pain with swallowing.At 1200 the patient was oriented to self and not answering additional orientation questions.Patient was not moving right upper extremity independently or to command, only able to elicit movement with noxious stimuli.App team and neurosurgery notified.Service assessed pateint at bedside.Placed head of bed flat per order and 1l ns bolus given.Stat cta completed.Patient kept npo.The site assessed the abulia as not related to the device or procedure.The sponsor assessed the abulia as possibly related to the procedure due to the time of the event onset.The patient has a past medical history of htn, diabetes mellitus, hypothyroidism, arthritis, headache, ble weakness, communicating hydrocephalus, demand ischemia, and confusion.
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
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 updated term/description of previously reported adverse event of "abulia/new infarction" to "bilateral cerebral infarct." following extubation on 12-jun, the patient had a decline in neurological status.The patient was non-verbal and not spontaneously moving right upper extremity (rue) or following verbal commands.Urgent computed tomography angiography (cta) and digital subtraction angiography (dsa) was completed.No additional need for intervention was identified.Subsequent magnetic resonance imaging (mri) showed "multifocal bihemispheric infarcts consistent with post-angio findings.The patient exam status worsened again on the morning of 16-jun, this time with the patient unable to follow commands involved in the left upper extremity (lue).Additional cta was completed with no evidence of vasospasm.Continuous electroencephalography (ceeg) was completed without evidence of seizures.The site assessed the event as having a causal relationship to the patient disease under study and no related to the procedure or devices utilized.However, the medtronic study sponsor assessed conservatively as possibly related to the procedure re due to the time of event onset.
Event or Problem Description
Additional information received reported that the patient experienced an ischemic stroke that resulted in prolonged hospitalization from (b)(6) 2024.
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 cec assessed as sae causally related to index procedure and possibly related to the study device and apt.Per cec it is a minor ischemic stroke in treated vascular territory.Corelab reviewed the ncct images taken on (b)(6) 2024 and reported "new hemorrhage along prior evd tract with new small intraventricular hemorrhage." site has already reported the stroke event post 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 resolved with sequelae on (b)(6) 2024.
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
Update b5.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.The sponsor assessment, that on (b)(6) 2025, indicated that the clinical events committee confirmed this was a non-disabling stroke.

• 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: 19568785
• Report Number: 2029214-2024-01101
• Device Sequence Number: 15190568
• Product Code: OUT
• UDI-Device Identifier: 00763000283940
• UDI-Public: 00763000283940
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 11/25/2025

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: 10/07/2024
• Device Model Number: PED2-275-20
• Device Catalogue Number: PED2-275-20
• Device Lot Number: B278670
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 08/02/2024; 09/04/2024; 12/13/2024; 10/28/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/14/2024; 09/24/2024; 01/09/2025; 11/25/2025
• Date Device Manufactured: 10/08/2021
• 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; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic
• Patient Race: White