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

Model Number	NV-4-10-HELIX
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): a concerto implant coil was returned within a shipping box; within a plastic biohazard bag; within a resealable plastic bag and within an opened concerto implant coil inner pouch.The concerto implant coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface was found to be separated and not attached to the coupler tube.The concerto pushwire was found to be broken at break indicator, kinked at ~39.9cm and bent at ~122.1cm from broken proximal end.This is indicative that a manual detachment was attempted.The coin was found still against the lumen stop with what appeared to be blood underneath the outer jacket.The shield coil was found intact with the implant coil still attached.The implant coil was found stretched and damaged with the polypropylene filament intact.No other anomalies were observed.Testing/analysis (including sem reports): the distal outer jacket was removed, and a manual detachment was then attempted by retracting the release wire and the release wire was successfully detached.Conclusion: based on the analysis performed, the concerto coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached.However, the implant coil was successfully detached manually during testing.The likely cause for the non-detachment are the bends and kinks found on the pusher, causing the release wire to become stuck.The implant coil was found damaged, and the pusher was found bent/kinked.Possible causes for coil and pusher damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its dispenser coil.Since the instant detacher was not returned, any contributing factors of the instant detacher to the non-detachment could not be determined.The root cause could not be determined.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 axium coil did not detach from delivery wire when wire was snapped.It was reported non-detachment occurred.The physician did not use an instant detacher, the wire was snapped.There was a manual attempt at detachment via hypotube.
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.
Additional Manufacturer Narrative
Update to h6: fdd code a0401 no longer applies to this event following new information received.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 was received stating that the cause of the non-detachment was related to an attempt to manually detach the coil, which remained on the delivery wire.The mention of the wire being snapped referred to the manual detachment process and not a separation or break of the coil pusher.The coil was not implanted and was removed from the patient while still attached to the delivery wire since the manual detachment did not work.Prior to the non-detachment, no issues were encountered.Additionally, no pushwire damage was 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: 23906388
• Report Number: 9617601-2025-03752
• Device Sequence Number: 13252937
• Product Code: KRD
• UDI-Device Identifier: 00847536044920
• UDI-Public: (01)00847536044920(17)280113(10)230456684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup
• Report Date (Section B): 02/10/2026

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-4-10-HELIX
• Device Catalogue Number: NV-4-10-HELIX
• Device Lot Number: 230456684
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 02/09/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/26/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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