MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	107F-079-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Paralysis (1997); Dysphasia (2195); Nervous System Injury (2689); Reduced Blood Flow (4598)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.Initial reporter information not reported due to region's privacy laws.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 a report that on december 16 (monday), treatment was performed for an unruptured aneurysm with an ic of 6-7 mm.Preoperative plan was after placing 2 coils with balloon assist, the microcatheter will be replaced and the pipeline will be placed.The rist was successfully guided smoothly to the vicinity of the cavernous area.An attempt was made about 3 times to access the aneurysm, and the microcatheter was successfully placed in the aneurysm.One apb-3-8-3d and one apb-3-6-3d were placed with balloon assist.Upon performing a contrast imaging using the rist, decreased peripheral blood flow was found (peripheral from m3).Healthcare provider (hcp) commented that there was a possibility that a thrombus might have released when induced to an aneurysm using the microcatheter.Pipeline placement was discontinued at the discretion of the hcp.Re-treatmentis scheduled at a later date after recovery of blood flow.2 apb-2-3-3d were added, and the procedure was completed.On march 10 (monday), it was reported that a patient in 40s developed a high-level functional disorder.Details are unknown, but the symptoms are speech impairment and lower half of the body paralysis.The cause was complications are on the way due to air getting in.The cause of the blood flow reduction in the peripheral blood vessels is unknown.The implantation procedure for the scheduled pipeline has not been performed to date.The device and any accessories were prepared as indicated in the package insert.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 7 mm and a 5 mm neck diam eter.It was noted the patient's blood flow was ordinary and vessel tortuosity was no anomaly.Ancillary devices include a rist7fr 105 cm guide catheter,sl-10 microcatheter, synchro select soft guidewire.
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 patient's high-level functional disorder/speech impairment/lower half of the body paralysis has not resolved.(b)(6) (monday): treatment for an unruptured aneurysm with an ic of 6-7 mm was performed.Preoperative plan: after placing two coils with balloon assist, the microcatheter will be replaced and a pipeline will be placed.Devices used: rist7fr 105 cm, sl-10/synchro select soft/septer xc/axium prime 4 units.Procedure: rist induction was successfully conducted smoothly to the cavernous vicinity.An attempt was made about 3 times to access the aneurysm, and the microcatheter was successfully placed in the aneurysm.One apb-3-8-3d, and one apb-3-6-3d was placed using the balloon assist.Upon performing a contrast study using the rist, it became clear that the blood flow in the peripheral blood vessels had fallen (peripheral from m3).Doctor commented that there was a possibility that a thrombus might have flowed when induced to an aneurysm using microcatheter.Doctor decided to discontinue the pipeline placement.Re-treatment is scheduled after recovery of blood flow at a later date.Two apb-2-3-3d were added, and the procedure was completed.January- the case was discontinued for a while due to continuing complications.Cause: complications are advancing in the direction of occurrence due to air in.
Event or Problem Description
Additional information received reported the patient developed major complications.
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.

• Brand Name: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: 21634646
• Report Number: 2029214-2025-00696
• Device Sequence Number: 18024340
• Product Code: QJP
• UDI-Device Identifier: 00763000413781
• UDI-Public: (01)00763000413781(17)270813(10)25102-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2025

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 Model Number: 107F-079-105
• Device Catalogue Number: 107F-079-105
• Device Lot Number: 25102-01
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 08/08/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/07/2025; 09/04/2025
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female