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

Model Number	NV-3-8-HELIX
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: instant detacher product id unk-nv-ap-id (lot: unknown);  concerto helix coil product id nv-3-8-helix (b)(6);  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 two concerto helix coils would not deploy.It was also reported that there was no alleged product issue.The product was replaced with a different model medtronic coil to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of an endoleak.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices included a merit maestro microcatheter.
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 was received stating that the endoleak was located as a post-evar type ii endoleak.The coils did not deploy because resistance was felt when attempting to insert them into the microcatheter.Kinking was found after a few attempts.Prior to coil non-detachment, resistance was encountered when attempting to insert the coil into the microcatheter.After removal from the patient, kinking was observed on the pushwire.
Additional Manufacturer Narrative
H3 product analysis: drawing(s) referenced: n/a as found condition: the concerto device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an introducer sheath.The unknown merit maestro micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.No evidence of detachment using an instant detacher was observed at this location.The pusher three tack welds were found broken with the release wire retracted.The concerto pusher was found bent at ~4.0cm from the proximal end and found kinked at ~8.2cm and ~45.5cm from the proximal end.The coin was found retracted out of the lumen stop.The implant coil was found already detached and found damaged within the introducer sheath.Testing/analysis: the concerto implant coil could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance in catheters include, but not limited to, lack of hydration before procedure, insufficient continuous flush, damaged micro catheter, or tortuous anatomy.Customer reported devices were prepared per ifu, and vessel tortuosity as moderate.Therefore, the root cause could not be determined.The customer report of ¿coil kink/damage¿ and ¿pusher kink/damage¿ were confirmed.Customer reported finding the damages after removal from the micro catheter.It is possible the implant coil and pusher became damaged due to advancing against the reported resistance.The customer report of ¿non-detach¿ could not be confirmed as the device was returned detached.The tack welds were found broken, the release wire was found retracted for the pusher, and the coin was out of the lumen stop, detaching the implant as expected by the detachment subassemblies.It is possible the kinks found on the pusher caused the release wire to become temporarily stuck, contributing towards the reported non-detachment.As the merit maestro micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the failures 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: 24183273
• Report Number: 9617601-2026-00611
• Device Sequence Number: 21258385
• Product Code: KRD
• UDI-Device Identifier: 00847536044906
• UDI-Public: (01)00847536044906(17)280616(10)231600525
• 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,Followup,Followup
• Report Date (Section B): 03/26/2026

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-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: 231600525
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 01/27/2026; 03/06/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/19/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Female