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

Model Number	REACT-71
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that on (b)(6) 2025, healthcare provider (hcp) was performing an emergency thrombectomy.The patient was an acute large artery occlusion patient with the lesion at the terminal of the internal carotid artery.The surgeon planned to use the solitact technology for thrombectomy.After the micro-guidewire micro-catheter established the access, the micro-catheter performed proximal and distal angiography to clarify the proximal and distal positions of the thrombectomy and prepare to deliver the thrombectomy stent.The stent selected was sfr-6-30.The surgeon reported that during the push process, there was great resistance near the y valve.The surgeon tried to increase the force to push, but the resistance was still great.The surgeon withdrew the stent, performed secondary hydration, and pushed again, but the same resistance phenomenon still occurred.For the sake of surgical safety, the surgeon did not push the stent with brute force, withdrew the stent, and observed the stent body morphology.The surgeon believed that the stent had some morphological changes.For the sake of surgical safety, delivering the stent again may increase the risk.The surgeon then replaced it with the sfr-4-20 thrombectomy stent, successfully delivered and deployed it, and after staying for five minutes, raised react-71, combined with pulling, and successfully completed the thrombectomy.There was resistance during the procedure during delivery.The vessel was not tortuous.The resistance occurred in the proximal section of the catheter.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a terminal of internal carotid artery ischemic stroke.It was noted the patient's vessel tortuosity was normal.The patient's baseline modified rankin scale (mrs) score was 4, procedure 4.Baseline national institutes of health stroke scale (nihss) 15, post procedure 4.Baseline tici 0, post-procedure 3.Iv tissue plasminogen activator (tpa) was not contraindicated.There were 2 passes with the device.Stroke onset to reperfusion time was 4 hours.Patient medical history includes high blood pressure.
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 stent detach point was suspected to be kinked.A continuous saline flush administered and maintained as indicated in the instruction for use (ifu).

• Brand Name: REACT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22150651
• Report Number: 2029214-2025-01310
• Device Sequence Number: 8347747
• Product Code: DQY
• UDI-Device Identifier: 00847536044197
• UDI-Public: 00847536044197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K182097
• 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
• Report Date (Section B): 06/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B662368
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 12/01/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG