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	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, an opened concert outer carton (lot- 228456399), within an opened concerto inner pouch (lot- 228456399).No microcatheter was returned.Visual inspection/damage location details: the concerto device was returned without the introducer sheath.The pushwire was found to be broken.The actuator interface, break indicator and the entire release wire were all found to be broken off and not returned; in addition, the remaining pushwire was found to be bent at ~44.7cm, bent at ~104.3cm from the broken proximal end of the pushwire.The concerto implant coil was found to be detached from the pushwire and not returned.The shield coil was found to be broken off and not returned.The coin was found to be retracted from the lumen stop with the rest of the release wire.No other anomalies were observed.Testing/analysis (including sem reports): none.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the concerto device was returned damaged with the implant detached from the pushwire and not returned for assessment.The damage found with the concerto device was determined to be consistent with advancement against resistance.A few possible causes of resistance in catheter during delivery¿ are but not limited to, incompatible catheter, tortuous anatomy, and/or damage or kink to pushwire; however, the root cause for the ¿coil resistance¿ was unable to be determined.Based on the device analysis and the reported information, the customer¿s report of ¿coil kink/damage¿ was unable to be confirmed.No implant coil was returned for assessment; therefore, no possible cause was determined.Regarding the break/separation damage, it is possible the damage may have occurred from the initial advancement against the reported resistance.No other issues were noted prior to use or during preparation.No microcatheter was returned; therefore, any contribution the catheter had towards the damage/resistance was unable to be analyzed.No lot or reference numbers were provided.Compatibility could not be confirmed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).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 concerto coil was being used as per the ifu but the coil was kinked and got stuck within the microcatheter.A new medtronic device was used to finish the procedure.The device and any accessories were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.It was noted the vessel tortuosity was unknown.Additional information received reported that the causes and contributing factors for the kink were not identified.Continuous catheter flush was administered during the procedure; all information was 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: 25448342
• Report Number: 9617601-2026-03661
• Device Sequence Number: 9465214
• Product Code: KRD
• UDI-Device Identifier: 00847536044920
• UDI-Public: (01)00847536044920(17)270311(10)228456399
• 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): 06/09/2026

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: 228456399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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