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

Catalog Number	CV-5-30
Medical Device Problem Codes	Entrapment of Device (1212); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil packing at the intended site for treatment of a right external femoral and profunda arteriovenous m alformation, a cv-5-30 versa coil prematurely detached from the pusher wire. two cv-6-20 coils were delivered without issue before the reported event. the artery measured 4mm, had minimal tortuosity, and abnormal vascular anatomy was reported.A 65cm 4fr non-medtronic (terumo glidecath) diagnostic catheter, a medtronic instant detacher, and a 45cm 6fr non-medtronic (terumo) sheath were used.The device was prepared according to the instructions for use, and a continuous heparinized saline flush was administered.The pusher delivery system was advanced more than 2 cm distally beyond the diagnostic catheter. the physician repositioned the coil and rotated the delivery pusher. the physician attempted to use the pusher wire to deliver the prematurely detached coil. the pusher wire got on other side of cv-5-30 coil and got stuck in the coil pack of the previously deployed cv-6-20 coils.After multiple different attempts to free the pusher wire were unsuccessful, the whole coil pack was removed from the patient and the case was started over. the issue was resolved on 20-aug-2026.Patient was treated with an abre stent, device was removed successfully with no injury to the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Imageanalysis the customer returned a video clip.The video clip shows a concerto versa coil being advanced towards a coil that has already been deployed.The reported event cannot be confirmed.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: 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: 50802465
• Report Number: 2029214-2026-01847
• Device Sequence Number: 10575934
• Product Code: KRD
• UDI-Device Identifier: 00763000936648
• UDI-Public: (01)00763000936648(17)290520(10)D115354
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K202850
• 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): 09/17/2026

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-5-30
• Device Lot Number: D115354
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 05/21/2026
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 210 LB