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

Model Number	REACT-68
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information regarding a patient who had undergone a mechanical thrombectomy procedure in which a react-68 aspiration catheter and solitaire x stent retriever were used on (b)(6) 2024.Iv tpa was contraindicated.Two passes were made.The procedure was to treat ischemic stroke in the right middle cerebral artery (r-mca) m2 segment.The patient's baseline tici was 0, mrs was 0, nihss was 10.Procedure mrs was 4 and post-procedure tici was 0, nihss was 7.It was reported that corelab report, a subarachnoid hemorrhage (sah) was noted in the 24-hour post-operative imaging.Site has not confirmed corelab observation.The patient was discharged on (b)(6) 2024 but it was reported the patient died (b)(6) 2024.Cause of death was not specified in the report.
Additional Manufacturer Narrative
Continuation of d10: product id sfr4-4-40-10 (b487481); 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
This event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplement reports are required unless additional information received indicates a reportable event.As there was no device malfunction, confirmed there was no subarachnoid hemorrhage event, and the patient's death was unrelated to any medtronic device or the procedure, the event no longer meets the definition of a complaint.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 site and study investigator confirmed there as no subarachnoid hemorrhage present on imaging.The patient died at the in-patient rehab facility.Autopsy records were not maid available but the site confirmed the event was related to the patient's pre-existing medical history of heart failure and was not due to subarachnoid hemorrhage.The patient death was unrelated to the study procedure or medtronic devices used in the procedure.As there was no device malfunction, confirmed there was no subarachnoid hemorrhage event, and the patient's death was unrelated to any medtronic device or the procedure, the event no longer meets the definition of a complaint per 027-wi185.This event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplement reports are required unless additional information received indicates a reportable event.

• 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: 23398943
• Report Number: 2029214-2025-02287
• Device Sequence Number: 13275028
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: (01)00847536041967(17)250227(10)B526749
• 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): 11/25/2025

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: 02/27/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B526749
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 03/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR
• Patient Sex: Female