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

Model Number	NV-3-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
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
Medtronic received a report that the concerto coil could not be deployed.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that a concerto coil (lot # 227008043) could not be deployed with the instant detacher, the customer refused to deploy manually.The physician attempted to detach the coil with the instant detacher 2 times, the physician did not try to detach with another detacher.There was no issue with the instant detacher.There was no manual attempt at detachment via hypotube.It was reported for a second concerto coil (lot # 230140611) used that the pushwire distal segment was bent after opening the package.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.No patient symptoms or complications were associated with this event.Ancillary devices include a direxion 0.021in x 130cm microcatheter.Additional information received that the cause of the event was not determined.The long black part of the coil pusher was inserted into detacher and pulled back the button, when nothing happened.There was no pushwire damage observed after removal from the patient.

• 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: 24680049
• Report Number: 9617601-2026-01979
• Device Sequence Number: 15895300
• Product Code: KRD
• UDI-Device Identifier: 00847536044890
• UDI-Public: (01)00847536044890(17)260719(10)227008043
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Expiration Date: 07/19/2026
• Device Model Number: NV-3-4-HELIX
• Device Catalogue Number: NV-3-4-HELIX
• Device Lot Number: 227008043
• 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: 08/21/2025
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 07/19/2023
• 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