MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-2-6-HELIX
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the product was being used as per the instructions for use (ifu) but the coil was kinked and got stuck within the microcatheter.A new medtronic device was used to finish the procedure.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Additional information received reported the coil came out of the introducer sheath smoothly.Continuous saline flush was administered and maintained as indicated in the ifu.The catheter was not a medtronic device.
Additional Manufacturer Narrative
Product analysis: as found condition: the concerto device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened concerto outer carton, within an opened concerto inner pouch and partially within an introducer sheath with the distal implant coil already deployed out the distal sheath.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the introducer sheath.Liquid and dried blood was found within the introducer sheath and on the pusher/implant.No damage or irregularities were found with the concerto pusher.The concerto implant coil was found damaged and stretched within and outside its introducer sheath with the polypropylene filament broken.Testing/analysis: the concerto device could not be advanced out of the introducer sheath as it was found stuck due to the blood.The concerto device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.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 NYLON
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22572967
• Report Number: 2029214-2025-01662
• Device Sequence Number: 9566855
• Product Code: KRD
• UDI-Device Identifier: 00847536044876
• UDI-Public: (01)00847536044876(17)280123(10)230536660
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: NV-2-6-HELIX
• Device Catalogue Number: NV-2-6-HELIX
• Device Lot Number: 230536660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 01/23/2025
• 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
• Patient Sex: Unknown