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

Model Number	PED3-021-250-10
Medical Device Problem Codes	Structural Problem (2506); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bacterial Infection (1735); Intracranial Hemorrhage (1891); Aphonia (4409); Ischemia Stroke (4418); Aspiration Pneumonitis (4455)
Date of Event	07/16/2024
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.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
Medtronic received information regarding a pipeline vantage that migrated and had fish-mouth deformation post-deployment and the patient experienced adverse events.It was reported that the patient had the pipeline implanted on (b)(6) 2024 to treat a right anterior cerebral artery (aca) unruptured saccular aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 3mm.Vessel tortuosity was normal.Dual antiplatelet treatment was administered.It was noted the pipeline vantage and all accessory devices were prepared per the instructions for use (ifu).The pipeline was implanted at the intended location and full wall apposition was achieved.No side branches were covered by the pipeline.Post procedure angiography showed great pipeline stent placement.The patient was discharged the day after the procedure.The patient began to experience stroke symptoms and arrived at the hospital emergency department (ed) on (b)(6) 2024.Angiography was completed and it was discovered that the pipeline had distal end fish-mouth and the stent had migrated approximately 2mm.The patient subsequently developed bilateral aca stroke and left hemispheric stroke.The patient was reported to have been intubated and admitted to the intensive care unit (icu) and remained as such at the time the event was reported to medtronic.It was additionally noted that the patient non-medtronic stent implanted on the right side which thrombosed and required integrilin to lyse the clot.Ancillary device: stryker atlas stent.
Event or Problem Description
Additional information received reported that complete wall apposition was achieved during the initial procedure without need for additional intervention.To treat the stroke event on (b)(6) 2024 integrilin was administered to address the thrombosed atlas stent.
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 that the patient was treated for a ruptured left posterior communicating artery aneurysm in 2023 ¿ it was treated with an atlas stent and coils.The patient had family history of deep vein thrombosis and was on medication to treat it; however, they stopped the medication a week prior to the intervention.It was noted that aneurysm treatment in the anterior communicating artery was considered off label.The patient was moved from the icu and their status continued to decline.They developed atrial fibrillation (afib), pneumonia, uti and subarachnoid hemorrhage.They are unable to swallow and speak and remain in the hospital.

• Brand Name: PIPELINE VANTAGE WITH 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: 19907109
• Report Number: 2029214-2024-01370
• Device Sequence Number: 21033450
• Product Code: OUT
• UDI-Device Identifier: 00847536036215
• UDI-Public: 00847536036215
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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 Model Number: PED3-021-250-10
• Device Catalogue Number: PED3-021-250-10
• Device Lot Number: B666402
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 08/13/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/13/2024; 08/13/2024
• Date Device Manufactured: 12/08/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female