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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the concerto implant coil was returned within a shipping box and inside of an opened concerto outer carton.Damage location details: the pushwire was found to broken at ~5.0cm , broken at ~6.0cm, bent at ~6.5cm, and broken at ~7.5cm from the proximal end.The implant coil was found to be broken off and not returned.The shield coil was found to be damaged.No other anomalies were observed.Testing analysis: no resistance testing was performed with an in-house microcatheter due to concerto condition (damaged).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil kink/damage¿ was unable to be confirmed; however, the event could not be ruled out.The concerto pushwire was found broken and bent.The likely cause for the coil kink/damage may have been caused by when the user ¿advances the device against resistance¿.The report notes that ¿that a concerto coil was found to have kink damage during the procedure.¿, this was unable to be confirmed.No implant coil was returned for further assessment; therefore, any contribution the implant coil had towards the damage was unable to be verified.Another possible cause of ¿coil kink/damage¿ would be patient vessel tortuosity; however, the root cause was unable to be determined.No mention of the patients vessel tortuosity was provided in the report.No microcatheter was returned for assessment; therefore, any contribution the microcatheter made towards the coil damage was unable to be verified.No information regarding the microcatheter was provided.Compatibility was unable to be confirmed.No mention of any preparation being performed was noted.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 a concerto coil was found to have kink damage during the procedure.The product was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.Additional information was received stating that there were no issues that resulted in the damage that was found.The information is confirmed by the physician.

• 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: 23547036
• Report Number: 9617601-2025-02721
• Device Sequence Number: 13123898
• Product Code: KRD
• UDI-Device Identifier: 00847536044869
• UDI-Public: (01)00847536044869(17)270415(10)228685755
• 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): 11/13/2025

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-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: 228685755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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