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

Model Number	PED2-400-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Headache (1880); Visual Impairment (2138)
Date of Event	12/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a patient who had a pipeline flex with shield implanted to treat a left internal carotid artery (ica) c4 segment saccular aneurysm via right radial access.The aneurysm max diameter was 19mm and the aneurysm neck was 6mm.After the pipeline was implanted, raymond and roy aneurysm occlusion class 3 was noted with significant stasis in the aneurysm observed.There was not reported device malfunction or deficiency.Post-operatively, neurological deterioration was noted; the patient experienced new hemianopsia/quadrantanopsia on the right with right drift.Magnetic resonance imaging (mri) showed scattered acute infarcts.The patient's dexamethasone was reduced to 2 every 12 hours.No additional treatment/intervention was reported.However, the event prolonged the patient's hospitalization.The event was not life-threatening and did not result in patient disability.The patient was noted to be recovering.Site assessment concluded the events were probably procedure related and possibly related to the pipeline and/or dual antiplatelet treatment (dapt).The device was successfully implanted.Wall apposition was achieved.Site branches (ophthalmic) were covered by the pipeline.Additional information received reported that a visual field defect was reported by the site, and it was assessed by the site as probably related to the index procedure and possibly related to the study device, rist catheter and antiplatelet medication.Brain mri and mra imaging was performed on (b)(6) 2022 after the patient reported right hemianopsia and right upper extremity drift.Images reported scattered acute infarcts in the left cerebral hemisphere involving the left corona radiata/centrum semiovale, left occipital pole, left basal ganglia, and left temporal lobe.The patient's blood pressure was medically controlled; heparin was discontinued and was continued on asa 81mg qd and brilinta 90mg bid.The aneurysm treated was fusiform.Additional information was received that the adverse event term was updated to stroke.The event resulted in a prolongation of existing hospitalization.The site assessed the event as possibly related to the rist catheter.Additional information received reported that the during admission for stroke work up on (b)(6) 2023, the patient complaint of a dull left sided headache that improved with a treatment of a migraine cocktail (tylenol, magnesium, reglan, and iv bolus).The headache recovered/resolved on (b)(6) 2023.The headache was not the result of a device deficiency, and was not a new or worsening of existing neurological deficient.The headache did not lead to a prolongation of hospitalization.It was noted that the patient had 3 pipeline devices successfully on (b)(6) 2022 with all apposition and neck coverage achieved.The site assessed the headache as possibly related to the disease under study and not related to the device or procedure.The sponsor assessed the headache as possibly related to the procedure, device, and disease under study.
Additional Manufacturer Narrative
This event was previously reported in manufacturer report#: 2029214-2022-02082 and 2029214-2023-00096.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 the site updated their assessment for the headache to not related to antiplatelet medication and possibly related to the device and procedure.The clinical events committee (cec) adjudicated the headache as not related to the device or 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 was received.Site related assessment stated that the study device and study procedure are not related.The sponsor assessment added that on 18-sep-2025: the clinical events committee (cec) adjudicated as not related to study device, and not related to study procedure.
Additional Manufacturer Narrative
Updated 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.
Additional Manufacturer Narrative
B5 updated 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 the patient stoke condition outcome status was updated to recovered/resolved with sequelae with an outcome date of (b)(6) 2022.Site related assessment was updated from probable to possible relationship to the study procedure.

• 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: 22879872
• Report Number: 2029214-2025-01884
• Device Sequence Number: 21293482
• Product Code: OUT
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/01/2026

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: 02/03/2025
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: B333447
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/04/2025; 02/18/2026; 09/03/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/26/2025; 10/30/2025; 03/13/2026; 10/01/2026
• Date Device Manufactured: 02/04/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 234 LB
• Patient Race: Black Or African American