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

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5 as found condition: two concerto devices were returned for analysis within a shipping box, within their opened concerto outer carton, within individual resealable plastic biohazard pouches, and within their introducer sheath.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the introducer sheath.A large amount of blood was found within the introducer sheath.The concerto pusher was found kinked between ~18.0cm and ~14.0cm from the distal end.The concerto implant coil was found damaged outside the introducer sheath.Testing/analysis: the concerto 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 for the first device as the damages found is consistent with resistance.A large amount of blood was found within the introducer sheath, potentially contributing towards resistance.It is possible that insufficient continuous flush was used, causing blood to backflow up the micro catheter and into the introducer sheath.Other possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, incompatible micro catheter, damaged micro catheter or tortuous anatomy.The returned concerto coil was found damaged, and pusher was found kinked.It is possible the damages occurred during the attempt to push the coil into the micro catheter against the reported resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be assessed.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.
Event or Problem Description
Medtronic received report that a concerto coil would not advance in the microcatheter.It was noted that the device was prepared as indicated in the instructions for use (ifu).The coil was replaced to complete the procedure.It was noted that there were no abnormalities reported related to the patient's anatomy.There was no harm or injury to the patient associated with this event.

• 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: 23285412
• Report Number: 9617601-2025-01974
• Device Sequence Number: 17510485
• Product Code: KRD
• UDI-Device Identifier: 00847536044883
• UDI-Public: (01)00847536044883(17)280410(10)231104956
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/13/2025

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-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: 231104956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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