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

Model Number	REACT-71
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the react catheter was kinked and resistance was felt during withdrawal.The patient was undergoing treatment for a plaque in the proximal section of the right carotid artery.It was noted the patient's vessel tortuosity was moderate.There was no calcification.There was chronic total occlusion.The patient was admitted to the emergency hospital with left limb immobility and diagnosed with acute cerebral infarction.It was reported that a balloon guide catheter was used for proximal support, and a non-medtronic guidewire and microcatheter were then used to advance through the lesion and reach the distal lesion.The microcatheter reached beyond the petrous vallecula of the internal carotid artery.Manual angiography confirmed that the microguidewire and microcatheter were in the true lumen and that distal blood flow was unobstructed.It was suspected that the patient's limb immobility was caused by a proximal origin occlusion, and recanalization of the origin vessel was planned.The guidewire was removed and exchanged with another guidewire, and a 5 embolic protection device was planned for distal protection.After removing the embolic protection device from the ring dispenser and fully hydrating, it went along the guidewire towards the embolic protection device.While advancing towards the embolic protection device, some resistance was felt, but the embolic protection device was successfully reached approximately 5 cm distal to the lesion and opened smoothly.The react-71 catheter was then used to aspirate the proximal stent.Aspiration revealed significant improvement within the stent, with blood flow restored.The aspiration catheter was then removed, and the embolic protection device was retrieved.The embolic protection device sheath went to the distal end of the stent and successfully retracted into the sheath.While withdrawing the embolic protection device from the stent into the subclavian artery, significant resistance was encountered and the embolic protection device and sheath remained in a semicircular shape.The surgeon then repeated the procedure, retracting the umbrella and sheath again.After repeated attempts, the embolic protection device and sheath still remained difficult to withdraw.The surgeon then used the aspiration catheter, the embolic protection device and sheath, retracting back into the aspiration catheter, and successfully retrieved the embolic protection device.Careful observation revealed deformation and significant kinking of embolic protection device guidewire.After 10 minutes of observation, the stent stenosis worsened again, prompting the surgeon to prepare for balloon dilatation of the stent.However, due to problems with the embolic protection device retraction, the surgeon replaced the embolic protection device with another of the same model, and the procedure proceeded smoothly.The guide wire was kinked about 10 cm away from the embolic protection device.The catheter was not gripped at the distal tip.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a 300 transend guidewire, ashi guidewire, and a 200 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 that the event was caused by the guidewire of the embolic protection device being deformed, which prevented proper withdrawal.The resistance was encountered during both delivery and retrieval.
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
D4: lot number updated.2.6: coding updated.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: 23144753
• Report Number: 2029214-2025-02083
• Device Sequence Number: 8888462
• Product Code: QJP
• UDI-Device Identifier: 00847536044197
• UDI-Public: (01)00847536044197(17)251020(10)B649630
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2025
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B649630
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 09/27/2025; 10/29/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/25/2025; 11/25/2025
• Date Device Manufactured: 11/02/2023
• 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: 63 YR
• Patient Sex: Male