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 Codes	Product Quality Problem (1506); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the concerto coil failed to pass through the microcatheter hub.The coil was stuck at the catheter hub.The coil was not damaged.Detailed information about the patient and devices used were not available due to a hospital policy.There were no patient symptoms or complications associated with this event.The device and any accessories were prepared as indicated in the instructions for use.Ancillary devices include a unknown microcatheter.Additional information was received stating that the exact cause of the event is unknown.The procedure was completed using a different coil, and continuous catheter flushing was performed during the procedure.
Additional Manufacturer Narrative
H3 product analysis: as found condition: the concerto device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened concerto outer carton and within an opened concerto inner pouch.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damage or irregularities were found with the concerto pusher.The detach element was still attached to the pusher.The concerto implant coil was broken from the detach element at the coil shell weld with the polypropylene filament also broken.Testing/analysis: the concerto device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance at catheter hub include, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, and use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).Customer asserts continuous flush was used.The cause of the resistance could not be determined.The returned concerto implant coil was found broken.The customer reported no damage to the coil.It is possible the damage occurred during the attempt to advance/retract the coil into the micro catheter hub 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 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.
Event or Problem Description
Additional information received reported the concerto coil was from trunk stock.The last cycle count was a month prior and cycle counts are conducted monthly.
Additional Manufacturer Narrative
B5 updated with additional 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.
Additional Manufacturer Narrative
H6.Coding updated based on additional 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.

• 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: 24783842
• Report Number: 9617601-2026-02270
• Device Sequence Number: 6133545
• Product Code: KRD
• UDI-Device Identifier: 00847536044883
• UDI-Public: (01)00847536044883(17)260104(10)225707688
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/29/2026

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 Expiration Date: 01/04/2026
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: 225707688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 04/16/2026; 06/02/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/08/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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