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

Model Number	REACT-68
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/08/2024
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 patient who underwent a thrombectomy procedure on (b)(6) 2024 for treatment of ischemic stroke.A react-68 aspiration catheter and solitaire platinum (sfr3) stent retriever were used in the procedure.There was no reported device malfunction.The patient's baseline tici was 0; nihss was 13.Tici 2b was achieved in the procedure.It was reported that in post-operative imaging on (b)(6) 2024, hemorrhagic transformation of the infarct area was observed that had not be noted in index procedure imaging.There was no additional treatment or intervention for the hemorrhage event and it was noted to be resolving and the patient is recovering.The event was not considered life-threatening and did not result in patient disability, nor did it prolong the patient's hospitalization.Site assessment concluded the event was not related to the procedure or medtronic devices.The medtronic study sponsor assessment concluded the event was possibly related to the procedure.2024-aug-26 (b)(4) (for, hcp, sdy): additional information was received that the outcome was recovered/resolved on (b)(6) 2024.Additional information received reported the mrs score was 0.Additional information received reported the intracranial hemorrhage was treated with intravenous (iv) mannitol.Thus, the study sponsor adjudicated the assessment of the of the event to indicate the adverse event was considered serious.The site assessment of the event was adjudicated to note that though not definitive, the event was considered to be related to the patient disease under study/index stroke and possibly related to the procedure.
Event or Problem Description
Additional information received reported that cec confirmed the event was caused by the study 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.

• Brand Name: REACT CATHETER
• 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: 22583138
• Report Number: 2029214-2025-01680
• Device Sequence Number: 4501956
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: (01)00847536041967(17)250502(10)B559153
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K180715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 05/02/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B559153
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 05/04/2023
• 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: Other
• Patient Sex: Female
• Patient Weight: 61 KG