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 Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding concerto coil premature detachment.It was reported that the concerto coil and all accessory devices were prepared as indicated in the instructions for use.The concerto coil was inserted but positioning was not what was desired so it was removed for discussion and repositioning.There was no friction of other difficulty during delivery of the coil.Continuous flush was administered during the procedure.When inspecting the coil to reinsert, it detached from the pusher wire.The doctor had not attempted to detach the coil at any point.At that point no kink or bend was noticed on the wire.However, the technician reported accidentally kinking the pusher wire when repacking the device in the plastic housing.The premature detachment occurred outside the patient's body so it was considered there was no patient involved.
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.
Event or Problem Description
Additional information received.The vessel was either the rima or lima.Size or tortuosity were not known.Procedure was completed with another coil.No know causes for premature detachment.
Additional Manufacturer Narrative
B5: additional information added to event summary.H3: product analysis as found condition (condition of returned device): a concerto coil was returned for analysis within a shipping box; within sealed biohazard bag; within an opened concerto implant coil inner pouch and within a dispenser track.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium coil pushwire was found to be broken and separated at ~141.9cm from proximal end.The distal broken segment of the concerto coil pushwire was found to be kinked at ~4.1cm from its broken proximal end.The coin was found to be pulled back and not against the lumen stop.The coin was found to be removed from pushwire assembly.The implant coil was already detached and not returned.No other anomalies were observed.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium implant coil was returned with the implant already detached; however, the root cause could not be determined.It is likely the premature detachment was due to the pushwire break causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon opening the package and attempting to remove the product or after removing it from the package and preparing it per ifu.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: 24433512
• Report Number: 9617601-2026-01411
• Device Sequence Number: 10243997
• Product Code: KRD
• UDI-Device Identifier: 00847536044951
• UDI-Public: (01)00847536044951(17)281001(10)232330616
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: 232330616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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