MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number	PED2-325-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Stenosis (2263); Obstruction/Occlusion (2422); Ptosis (2620); Aphonia (4409); Hemorrhagic Stroke (4417); Thrombosis/Thrombus (4440)
Date of Event	02/15/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that a patient treated with 3 pipelines had occlusive in stent thrombosis.Around 12:00 subject noted to be altered and refusing medications, in route to hospital subject developed right-sided weakness, right sided facial droop and aphasia.Nihss on admission = 24.Ct imaging showed right subarachnoid hemorrhage with parenchymal tract and right ventricle hemorrhage.Diagnostic angiogram showed occlusive clot within pipeline device.Iv aggrestat given with good effect.Mri showed small stroke burden.Subject started on dual antiplatelet therapy.The patient was hospitalized and treatment was given.The event is not resolved.One of the four pipelines was not implanted due to use error.Clarified as ¿due to significant tortuosity of the l m1, the investigator could not easily delivery the device to the top of the delivery microcatheter.The decision was made to remove the delivery microcatheter and the non-delivered device and proceed with a femoral artery approach¿.Safety assess this event as possibly related to the study device, procedure, and antiplt therapy.
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 that the access vessel was ¿radial right¿ and it was cross overed to transfemoral due to significant tortuosity.The patient was undergoing surgery in which is pipeline flex with shield technology implantation for acutely ruptured intradural aneurysm.
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 that the adverse event term was updated.Nihss 24 at admission and 9 at 24 hours post event and 7 at discharge.The site assessed as causally related to relationship to antiplatelet therapy, switched to dapt.Further information was received that per available information, patient was discharged on (b)(6) 2024 to rehab.Then, admitted again due to discussed symptoms on (b)(6) 2024.Hosptialization ended on (b)(6) 2024.The patient experienced altered, right sided weakness, right sided facial droop and aphasia related to the stroke.Ct scan reported intracerebral vascular occlusion in treated vascular territory.A benchmark catheter was used.It was updated that the reason the device was not implanted was due to device malfunction.
Event or Problem Description
Additional information received reported that the patient experienced asymptomatic cerebral artery stenosis on (b)(6) 2024.No additional treatment or hospitalization was given.The stenosis was noted as not recovered/not resolved.The adverse event was not the result of a device deficiency.The stenosis was assessed as possibly related to the disease under study, not related to the procedure, and caused by the pipeline.It was also noted that the patient stopped taking ticagrelor/brilinta 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.
Event or Problem Description
Additional information received reported (b)(4) cerebral branch artery stenosis.
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 cec adjudication 22jan2025: causally related to the study device.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: LASER THERAPY PRODUCT
• 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: 18964156
• Report Number: 2029214-2024-00500
• Device Sequence Number: 15466756
• Product Code: OUT
• UDI-Device Identifier: 00763000284053
• UDI-Public: 00763000284053
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 10/13/2024
• Device Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B281716
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 03/26/2024; 08/30/2024; 09/19/2024; 01/24/2025
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 03/26/2024; 04/16/2024; 09/06/2024; 10/04/2024; 01/31/2025
• Date Device Manufactured: 10/14/2021
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 92 KG