MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-6-20-HELIX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the product was being used as per the ifu but the coil was kinked within the microcatheter.A new medtronic product used to complete the procedure.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.Additional information received reported there were no issues that resulted in the damage that was found.There were no issues with the catheter.The catheter was not a medtronic product.
Additional Manufacturer Narrative
This event is reported at this time based on analysis findings which indicated a reportable event.H3.Product analysis: equipment used: video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the concerto device was returned for analysis within a shipping box; within a resealable plastic biohazard pouch; within an opened concerto inner pouch and without its dispenser coil or introducer sheath.The unknown non-medtronic micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the concerto pusher was found broken at the positive load indicator.The release wire was found extending out of the break location and found broken/separated from the actuator interface.The concerto implant coil was found damaged.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil kink/damage¿ was confirmed.It is possible the implant became damaged due to advancing against resistance.The pusher was found broken at the positive load indicator.Customer did not report attempting to detach the device.Customer did not report finding the damage during inspection/preparation per ifu; therefore, the damages likely occurred during use.Customer reported devices were prepared per ifu, no issues that contributed towards the failure, and no issues were found with the micro catheter.Therefore, the likely cause of the coil kinking and pusher break could not be determined.As the unknown micro catheter used during the event was not returned for analysis, any contribution of the micro catheter towards the failure could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22040086
• Report Number: 9617601-2025-00473
• Device Sequence Number: 9280488
• Product Code: KRD
• UDI-Device Identifier: 00847536044951
• UDI-Public: 00847536044951
• 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): 05/16/2025

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-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: 229381324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Patient Sex: Unknown