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	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during the delivery the solitaire fr stent encountered resistance in the middle of the catheter.The stent delivery was difficult and the cause of resistance was unclear.The patient was undergoing treatment for ischemic stroke from the end of the internal carotid artery to the middle cerebral artery m1.It was noted the patient's vessel tortuosity was minimal.The patient's baseline modified rankin scale (mrs) score was 4, which remained the same following the procedure.The national institutes of health stroke scale (nihss) score significantly improved, decreasing from a baseline score of 19 to 3 post-procedure.The thrombolysis in cerebral infarction (tici) score also improved from 0 at baseline to 3 post-procedure.Intravenous tissue plasminogen activator (iv tpa) was not contraindicated in this case.The procedure involved two passes with the device.The stroke onset to reperfusion time was 4 hours.It was reported that the surgeon was performing an emergency thrombectomy surgery.The surgeon used the solitact technology, react71 catheter and ruikangtong microcatheter, after determining the distal and proximal positions, they delivered the stent through the microcatheter.After the stent was delivered for about 30cm, the resistance increased, so the stent was withdrawn, hydrated again according to the process, flushed the passage, and delivered again, but it still could not enter.It was replaced with the stent of another manufacturer, which was successfully put in place, deployed, and pulled out, and thrombectomy were combined to end the surgery.It was noted that the vessel was not tortuous.There was no kink or damage on the catheter, also no damage on the pushwire of the solitaire.The tip of the solitaire sheath was already secured into the hub of the microcatheter.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
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 was received stating that there was no definite answer on whether the resistance occurred in the react-71 or the non-medtronic catheter or both.The patient was under local anesthesia during the operation.When the situation occurred, the surgeon was emotional.This phenomenon had not occurred in the past when sfr-6-30 was used.After reconfirming with the surgeon, the surgeon noted that the resistance during the operation was large and the stent could not move forward.
Additional Manufacturer Narrative
H6.Fdm/imdrf annex b code updated.Follow up indicated the device was discarded by the customer.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: 22150966
• Report Number: 2029214-2025-01312
• Device Sequence Number: 7639166
• Product Code: QJP
• UDI-Device Identifier: 00847536044197
• UDI-Public: (01)00847536044197(17)261114(10)D004631
• 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): 07/23/2025

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: D004631
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/08/2025; 06/26/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/23/2025
• Date Device Manufactured: 12/11/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 60 KG