MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5081-153
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id sfr-4-20 (d024746); product type: ; implant date n/a; explant date n/a 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 considering the patient's preoperative condition of middle cerebral artery occlusion, severe ischemic symptoms, young age, and status as the mainstay of the family, the operator first used an aspiration catheter during the procedure.After one attempt at aspiration, the vessel remained occluded.Subsequently, a 4-20 fr thrombectomy stent was used in combination with aspiration.When the stent reached the lesion site, there was resistance while pushing out the stent.After overcoming the resistance, continued to open the stent and left in place for a few minutes.The stent was then retracted together, and a small amount of bright red thrombus was found.Angiography revealed poor vessel patency, so a second combined stent retrieval and aspiration was performed.The result was similar to the first attempt, and complete recanalization was not achieved.The operator then planned to detach using a detachment box and battery, attempting twice and switching to a new battery midway, but detachment was unsuccessful.Considering the prolonged operative time, the procedure was concluded.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 an ischemic stroke located in the m1 segment occlusion of the middle cerebral artery.It was noted the patient's vessel tortuosity was moderate.The patient's baseline modified rankin scale (mrs) score was 4, post procedure score was 1.Baseline national institutes of health stroke scale (nihss) was 18, post procedure score was 5.Baseline tici was 0, post procedure score was 2b.There was 1 pass of the device.Stroke onset to reperfusion time was 4 hours.Ancillary devices include a 8f90 long sheath, react71 guide catheter, avigo 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 was received that the cause of the event was suspected that the stent detachment syringe needle did not penetrate the muscle layer, or that the stent detachment point was positioned against the blood vessel wall.There was resistance at the distal end of the stent, and the stent did not advance when the operator pushed the stent guidewire.There was a continuous infusion of saline solution through the microcatheter.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 23764544
• Report Number: 2029214-2025-02582
• Device Sequence Number: 9742649
• Product Code: KRA
• UDI-Device Identifier: 00763000539344
• UDI-Public: (01)00763000539344(17)261204(10)D002127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093750
• 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): 01/13/2026

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 Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: D002127
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/14/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 12/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 39 YR
• Patient Sex: Male