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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding two concerto coils of the same model/lot that had resistance in the microcatheter during delivery.It was reported that the concerto coils and all accessory devices were prepared as indicated in the instructions for use (ifu).The coils got stuck at the middle segment of the microcatheter.There was no damage observed to the coils or the catheter.There was no patient injury associated with this event.Additional information was received stating that the coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.The catheter used was not a medtronic product; instead, a boston truselect 021 microcatheter was utilized.The information is confirmed by the physician.
Additional Manufacturer Narrative
H3: product analysis as found condition: the concerto device was returned for analysis within a shipping box, within an opened concerto outer carton, within an opened concerto inner pouch, within a dispenser coil and within an introducer sheath.The boston truselect 021 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The concerto pusher was found broken at ~46.3cm from the distal end with the release wire partially retracted and found kinked at ~20.3cm from the distal end.The concerto implant coil was found already detached and damaged.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 as the damages found is consistent with resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, or tortuous anatomy.The returned concerto coil was found damaged and the pusher was found kinked/broken.The customer reported the coil came out of the introducer sheath smoothly and did not report finding damage to the coil during preparation; therefore, it is possible the damages occurred due to advancing against the reported resistance.Customer reported devices were prepared per ifu, and continuous flush was used.Therefore, the root cause could not be determined.As the boston truselect 021 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be assessed.The concerto coil is compatible for use with the truselect 021 micro catheter (0.021¿ inner diameter).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: 24223436
• Report Number: 9617601-2026-00807
• Device Sequence Number: 8197051
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: (01)00847536044975(17)271017(10)229914009
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/30/2026

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-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 229914009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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