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

Model Number	REACT-71
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Death
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 a report that the react catheter was found kinked.The patient was undergoing a mechanical thrombectomy treatment for an acute ischemic stroke.The accessed vessel was the femoral artery with a diameter of 7.6 mm.It was noted the patient's vessel tortuosity was severe.It was reported that the patient had basilar artery occlusion, poor vascular development, and abdominal blood vessels with abdominal aortic aneurysm.After puncture, a 0.035 loach guidewire + 125cm angiography catheter with a 90cm long sheath of li kai reached the middle section of v1, and was replaced with a tresend 3m guidewire + rebar 18 with react 71 and delivered to the v4 section.The micro-guidewire and micro-catheter further broke through the basilar artery apex, and react was difficult to follow up, so the whole system was withdrawn and the long sheath delivery was performed again.The long sheath was delivered to the upper end of v1 for the second time, and tresend 3m guidewire + rebar 18 with react 71 was delivered again.The guidewire could not break through the basilar artery occlusion stage.After repeated attempts failed, react 71 was raised for aspiration, and a little thrombus was aspirated.After the guidewire was raised again and could not break through, the whole system was withdrawn, and it was found that the distal end of react was kinked.The surgery was over and the patient was sent to the icu.It was reported the catheter was kinked in the distal section.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptomsor further complications were reported as a result of this event.Ancillary devices used were: 8f femoral artery puncture sheath, locaste 0.88 inch 90cm guide catheter, rebar 18 0.021 in 153 cm microcatheter, boston scientific tresend 0.014 inch 300 cm guidewire additional information was received that the patient is recovering well.The procedure was completed after replacing the solitaire fr 6-30, it was delivered to the distal end of m1 through a microcatheter and then opened.Using the stent anchor, the intermediate catheter was delivered to the beginning of m1 and the swim technique was used to remove the thrombus successfully.There was no additional medical or surgical intervention.After being transferred to the icu, the patient received standard treatment and postoperative recovery and is currently recovering well.It was noted that the cause of the catheter kink/difficult navigation was speculated that the reason might be that when the stent was delivered through rebar 18, the gap between the tail end of the microcatheter and the stent was too small, resulting in resistance during pushing and causing the stent to break.
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 has died.The surgery was completed after the middle catheter was removed.Since the guidewire could not reach the distal occlusion after repeated probing, no subsequent operation was performed.The thrombus was not removed.No additional medical intervention were done for the patient.After the operation, the patient was sent to the intensive care unit (icu) according to normal procedures and was discharged three days later.
Event or Problem Description
Additional information received reported the patient died at home.The cause of death was not thought to be related to medtronic device or therapy.
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
Product analysis: as found condition: the react-71 catheter was returned for analysis within a shipping box, a plastic bio-pouch, and a dispenser coil.Damage location details: no damages were found with the react-71 catheter hub.The react-71 catheter body was found stretched from ~17.5cm to ~15.5cm from the catheter distal tip.The react-71 catheter distal marker/tip was found crushed.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
• 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: 21253543
• Report Number: 2029214-2025-00227
• Device Sequence Number: 8075078
• 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,Followup,Followup
• Report Date (Section B): 04/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2025
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B601239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 03/11/2025; 04/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/03/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: Death
• Patient Age: 58 YR
• Patient Sex: Male