MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 CONCERTO VERSA; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	CV-4-15
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment for ¿hypo take down,¿ a concerto versa coil was prepared as indicated in the instructions for use and tracking difficulty occurred during initial advancement and resistance/sticking occurred in the catheter at the hub. physician hubbed introducer sheath to catheter and felt resistance advancing into a 2.8 non-medtronic microcatheter. physician pulled back and tried to re-advance and felt resistance again.When physician pulled coil back , the coil had prematurely detached inside the microcatheter. the pusher release wire was bent/broken. the detached coil was removed from the patient.A replacement concerto versa cv-3-15 coil was used to complete the procedure and the issue was resolved.No patient complications have been reported as a result of 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CONCERTO VERSA
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50880892
• Report Number: 2029214-2026-01903
• Device Sequence Number: 10667517
• Product Code: KRD
• UDI-Device Identifier: 00763000936624
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K253511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Catalogue Number: CV-4-15
• Device Lot Number: D090091
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/22/2026
• 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 Sex: Male