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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that since the physician was using the coil for the first time, they requested to see it during the procedure.Under the supervision of the medtronic representative, one coil was taken out and handled.They had been asked to process it as a sample.Additional information was received stating that it was unknown if any issue occurred with the concerto coil.Procedure completion and cause of event were also unknown.The information is confirmed by the physician.Additional information was received confirming that there was no device issue with the concerto coil.
Additional Manufacturer Narrative
H3: product analysis as found condition: the concerto implant coil was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened concerto outer carton, within a concerto inner pouch, within a dispenser coil, and within an introducer sheath.Damage location details: the concerto had the sheath applied correctly with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was found to be in good condition.The actuator interface was found to be loose, with the release wire pulled (implant coil not returned).The break indicator was found to be intact.The pushwire was found to be bent at ~6.8cm from the proximal end.The pushwire was also found to be bent within the introducer sheath at ~6.3cm from the distal end.The concerto implant coil was not returned.Additionally, the implant coil's polypropylene filament was found to be detached from the implant coil.The concerto implant coil was able to advance outside of the introducer sheath without any issues.No other anomalies were observed.Testing analysis: the concerto implant coil could not be used for resistance testing with an in-house catheter due to its damaged co ndition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿no device malfunction reported¿ could not be confirmed, and the root cause could not be determined.The concerto coil implant coil was returned damaged, with the pushwire bent.Advancing the implant coil against resistance may lead to possible damage; therefore, it is possible that the damage occurred during preparation.This cannot be confirmed.The actuator interface was found loose, with the release wire pulled.This could have been caused by advancing the coil against resistance.This was unable to be determined.The report states that ¿under the supervision of the medtronic representative, one coil was taken out and handled.They had been asked to process it as a sample.¿.It could be possible that the returned device was the sample device.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
Correction made to h3: product analysis as found condition: the concerto implant coil was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened concerto outer carton, within a concerto inner pouch, within a dispenser coil, and within an introducer sheath.Damage location details: the concerto had the sheath applied correctly with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was found to be in good condition.The actuator interface was found to be loose, with the release wire pulled (implant coil not returned).The break indicator was found to be intact.The pushwire was found to be bent at ~6.8cm from the proximal end.The pushwire was also found to be bent within the introducer sheath at ~6.3cm from the distal end.The concerto implant coil was not returned.Additionally, the implant coil's polypropylene filament was found to be detached with the implant coil.The concerto implant coil was able to advance outside of the introducer sheath without any issues.No other anomalies were observed.Testing analysis: the concerto implant coil could not be used for resistance testing with an in-house catheter due to its damaged co ndition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿no device malfunction reported¿ could not be confirmed, and the root cause could not be determined.The concerto coil implant coil was returned damaged, with the pushwire bent.Advancing the implant coil against resistance may lead to possible damage; therefore, it is possible that the damage occurred during preparation.This cannot be confirmed.The actuator interface was found loose, with the release wire pulled.This could have been caused by advancing the coil against resistance.This was unable to be determined.The report states that ¿under the supervision of the medtronic representative, one coil was taken out and handled.They had been asked to process it as a sample.¿.It could be possible that the returned device was the sample device.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: 22195662
• Report Number: 9617601-2025-00542
• Device Sequence Number: 9189169
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: 00847536044975
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Expiration Date: 03/28/2026
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 226235089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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