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

Model Number	PED2-325-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hearing Impairment (1881); Stenosis (2263); Unspecified Nervous System Problem (4426)
Date of Event	06/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a pipeline patient experienced bruising.No hospitalization or additional surgical intervention was reported.The patient was not recovered/resolved.It was noted that the adverse event was not related to the disease under study.The patient experienced an ease of bruising specifically in the left groin and into the thigh.There was no reported treatment given due to the bruising.The site assessment of the event indicated the event was probably related to antiplatelet medication.The patient was being treated for a right c6 ica aneurysm with a saccular morphology.Location of aneurysm was in the sidewall of the vessel.Aneurysm dimensions: maximum diameter 6.8 mm, dome height 6.8 mm, dome width 4.7 mm, neck size: 3.5 mm, parent artery diameter distal to aneurysm 3.5 mm and parent artery diameter proximal to aneurysm 4.1 mm.No stasis was noted at the end of the procedure.Post implant complete neck coverage was obtained.Post implant the aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.The patient was being treated for one aneurysm with access via the femoral right.Rist was not used.The study device was successfully implanted in the subject.Wall apposition was achieved.The side branches were not covered by the pipeline device.No device flattening or twisting was noted.Ancillary devices: guide catheter infinity 088, intracranial support catheter navien 058, microcatheter phenom 027 additional information received reported that the patient has been experiencing right side pulsatile tinnitus since 15-aug-2024.They were given methylprednisone to treat, and underwent ct imaging for diagnosis.The event was not recovered/not resolved.No additional hospitalization was needed.The event was considered a new or existing neurological deficit lasting more than 24 hours, and was not the result of a device deficiency.The site assessed the adverse event as possibly related to the disease under study and not related to the device or procedure.The sponsor assessed the event as possibly related to the procedure as a precaution.
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
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 not related to device, procedure, or antiplatelet treatment.
Event or Problem Description
Additional information received reported that at the 1-year follow-up on (b)(6) 2025 mrs was recorded as 1 when mrs at 180-day visit had been recorded as 0, indicating a neurological deterioration though no significant patient disability.No other information was provided.
Additional Manufacturer Narrative
B5 updated with additional information received.H6 patient coding updated based on 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.
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 there was parent artery stenosis (in stent stenosis).This adverse event (ae) did not lead to hospitalization, blood transfusion, surgical intervention, treatment with a percutaneous intervention or treatment in another manner.The outcome status is not recovered/not resolved.Ae occurred post procedure and was possibly related to the disease under study.Ae did not result in a new or worsening of existing neurological deficits and did not result from a device deficiency.There was parent artery stenosis >50% discovered at the 1 year imaging.The site assessed that this event did not lead to congenital anomaly, death, disability, medical intervention, or hospitalization and was not considered life-threatening.The site assessed this event was not related to the antiplatelet medication, retreatment procedure, rist catheter, or study procedure, and was possibly related to the study device.The sponsor conservatively assessed as possibly related to the study device.Corelab review of the 1 year imaging confirms parent artery stenosis >50%.
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
It was reported that 1-year imaging on (b)(6) 2025 identified parent artery stenosis of 51%-75% and anterior cerebral artery stenosis of 50% following use of the pipeline flex shield.It was unknown if there was any patient involvement or complications as a result of the event.Additional information received reported no symptoms were reported related to the stenosis.No actions were taken.
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 the cec adjudicated the stenosis as possibly related to the procedure, device, and antiplatelet therapy.The site updated their assessment of the stenosis to possibly related to the procedure and antiplatelet medication.

• 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: 21648143
• Report Number: 2029214-2025-00712
• Device Sequence Number: 7498673
• Product Code: OUT
• UDI-Device Identifier: 00763000284053
• UDI-Public: (01)00763000284053(17)250127(10)B329849
• 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: 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): 09/30/2026

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: 01/27/2025
• Device Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B329849
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 06/18/2025; 07/22/2025; 08/08/2025; 09/19/2025; 09/01/2026
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/23/2025; 06/24/2025; 08/08/2025; 08/28/2025; 10/19/2025; 09/30/2026
• Date Device Manufactured: 01/28/2022
• 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: Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 228 LB
• Patient Race: Black Or African American