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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a solitaire ab stent was damaged during the procedure and encountered resistance the patient was undergoing surgery for treatment of a m1 ischemic stroke.The mrs baseline and procedure score was 1.The nihss baseline and post procedure score was 1.The tici score baseline and post procedure was 0.Iv tpa (intravenous tissue plasminogen activator) was not contraindicated.There were 2 passes with the device.It was noted the patient's vessel tortuosity was normal.Stroke onset to reperfusion time was 2 hours.It was reported that the patient had acute cerebral infarction and underwent thrombectomy in the right middle cerebral artery m1 segment.During the procedure, the sab-6-30 was used for thrombectomy.During delivery through the middle segment of the rebar18, the stent became stuck in the microcatheter.After the stent was removed, it was observed that the tail end of the stent had a kink, and the tail end of the stent was severely deformed.After the stent was replaced, the procedure proceeded smoothly.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 rebar 18 microcatheter.Additional information was received reporting that no causes or contributing factors for the event were identified.Catheter resistance occurred in the middle of the device.A continuous saline flush was administered and maintained as indicated in the ifu.
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.

• 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 ; +1(763)526-5677
• MDR Report Key: 50936804
• Report Number: 2029214-2026-01946
• Device Sequence Number: 10725499
• Product Code: KRA
• UDI-Device Identifier: 00763000539344
• 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
• Report Date (Section B): 09/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: D017836
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOLITAIRE AB 6-30 STENT SAB-6-30 (LOT D013323)
• Patient Sex: Male