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

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	06/30/2025
Type of Reportable Event	Malfunction
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 a solitaire encountered resistance in the middle of the react and the stent pushwire was broken in the distal section.The patient was undergoing emergency interventional thrombectomy for treatment of ischemic stroke in the middle cerebral artery.Patient condition: mrs baseline: 4, mrs procedure: 4, nihss baseline: 15, nihss post procedure: 4, tici baseline: 0, tici post procedure: 3.Iv tpa was not contraindicated.There was 1 pass with the device.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with an 11mm diameter.Patient has a medical history of hypertension level 2.Stroke onset to reperfusion time was 4.5 hours.It was reported that on (b)(6) 2025, the surgeon was performing an emergency thrombectomy on a patient with acute large artery occlusion.The lesion was located at the middle cerebral artery at the end of the internal carotid artery.The surgeon planned to use the solitact technology to remove the thrombus.After the micro-guidewire and micro-catheter established the pathway, the micro-catheter performed proximal and distal angiography to determine the proximal and distal positions of the thrombus removal and prepare for the delivery of the thrombectomy stent.The stent selected was sfr-6-30.The surgeon reported that the delivery and deployment were smooth.After staying for five minutes, the react-71 was pushed to go upper, and carry out the combination of drawing and pulling.After the stent was withdrawn, it was found that the thrombectomy stent was broken in the react-71.The stent and react-71 were replaced, and the thrombus was removed for the second time.The surgery was successfully completed.The pushwire was not torqued during the procedure.Resistance was encountered.All broken segments of the pushwire were removed from the patient.Since the segments were broken in the suction catheter, the surgeon removed the suction catheter and changed the access.The stent was removed from the patient.The reported devices and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a ced medical-27 microcatheter.
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 cause of the resistance and pushwire break was not determined.The catheter was vi sually inspected and there was no problem, and the stent was inside the catheter.The tip of the solitaire sheath was firmly secured in the hub of the microcatheter.
Additional Manufacturer Narrative
Product analysis: as found condition: the solitaire fr 6-30 stent was returned for analysis, stuck inside the returned react-71 catheter, enclosed in a sealed biohazard bag and a shipping box.The solitaire stent pusher wire was not returned.The reported ced medical 27 microcatheter was not returned.Additionally, the model was not reported.Damaged location details: the solitaire fr 6-30 stent¿s working and non-working length struts were in good condition.The glue domes outside the proximal marker were observed to be damaged.It was observed that the solitaire stent was broken at the detachment zone.However, the proximal broken end of the pusher wire was not returned.Therefore, no sample could be sent out for scanning electron microscopy (sem) failure analysis testing.No voids or flashes were found on the react-71 catheter hub.No bends or kinks were found on the catheter body.The catheter distal tip/marker was found to be compressed/flattened.No other anomalies were found.Testing/analysis: the react-71 catheter was dissected (cut), and the solitaire fr 6-30 stent was removed.The total and usable lengths of the react-71 catheter were measured within the specified limits.The react-71 catheter was flushed with water and was found patent, tested via an in-house 0.050¿ mandrel through the hub without issues; however, resistance was observed at the distal tip.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: 22394421
• Report Number: 2029214-2025-01500
• Device Sequence Number: 18398202
• Product Code: QJP
• UDI-Device Identifier: 00847536044197
• UDI-Public: (01)00847536044197(17)270212(10)D019098
• 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): 08/29/2025

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 Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: D019098
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/04/2025; 08/28/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG