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

Model Number	NV-5-20-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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 cause of the premature deployment was not determined.There was no damage to device packaging.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.No damage to packaging was noted on delivery.No kink on the pushwire noted on delivery or opening packaging.
Event or Problem Description
Medtronic received a report that upon opening the sterile package, the coil appeared to be prematurely deployed inside the packaging.Visible damage to the packaging was noted, and the device was not able to be properly used.The premature deployment was observed prior to removal from the hoop/tray, indicating that the product had deployed before any procedural handling.The sheath french size and brand are unknown, and guidewire information was not available.The device was not passed through a previously deployed stent.Instructions for use (ifu) adherence, including mvp plug soaking in heparinized saline and maintenance of continuous flush, could not be confirmed.The catheter was not flushed before plug insertion because the device had already deployed while in the packaging.There was no patient involvement.
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.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): a concerto coil was returned for analysis within a shipping box; within an opened concerto implant coil inner pouch and within a dispenser track.The concerto implant coil was returned within introducer sheath visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The break indicator was found intact.This is indicative that a manual detachment was not performed.The concerto pushwire was found to be kinked at ~4.4cm from proximal end.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant coil appeared to be damaged within introducer sheath.The implant coil was pushed out from introducer sheath for additional analysis.The implant coil was found damaged with the polypropylene filament intact.No other anomalies were observed.Testing/analysis (including sem reports): n/a.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the pushwire was returned with the implant coil still attached.Based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was confirmed as the pushwire was found to be kinked secured within the rubber stopper and in the dispenser coil clip.It is possible damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.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: 22464297
• Report Number: 9617601-2025-00605
• Device Sequence Number: 20796720
• Product Code: KRD
• UDI-Device Identifier: 00847536044944
• UDI-Public: (01)00847536044944(17)270711(10)229241667
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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-5-20-HELIX
• Device Catalogue Number: NV-5-20-HELIX
• Device Lot Number: 229241667
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 09/04/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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