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

Model Number	NV-3-8-HELIX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
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
Medtronic received a report that a concerto helix coil released from the wire inside the non-medtronic microcatheter.Coil separati on/break/premature detachment was noted.The coil was removed from the patient with the microcatheter.A new coil was used to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing embolization surgery for treatment of aortopulmonary collateral vessels.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Medical or surgical intervention was not needed to prevent a permanent impairment of a function, the event did not lead to or extend patient hospitalization, and there was no injury as a result of the event.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pushwire was not bent or broken.There was no friction or difficulty during delivery, the physician did not reposition or attempt to detach the coil.The delivery pusher was not rotated during the procedure.Continuous flush was administered during the procedure.Ancillary devices include: cobra 5f guide catheter, excelsior microcatheter.
Additional Manufacturer Narrative
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, within an opened concerto inner pouch, within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The shield coil was found undamaged.The implant coil was still attached to the pusher.The implant coil was found damaged within the introducer sheath.The implant coil tip was found still attached to the implant (implant unbroken).Testing/analysis: n/a conclusion: based on the analysis performed, the customer report of ¿premature detachment" or ¿coil separation break¿ could not be c onfirmed.The implant coil was returned still attached to the pusher and unbroken.The implant coil was found kinked, likely due to advancing against resistance.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.The cause of the premature detachment/break/separation was not determined.The push cable is being returned.

• 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: 23063925
• Report Number: 9617601-2025-01460
• Device Sequence Number: 9987519
• Product Code: KRD
• UDI-Device Identifier: 00847536044906
• UDI-Public: (01)00847536044906(17)260801(10)227053099
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 12/27/2025

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: 08/01/2026
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: 227053099
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 12/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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 Age: 3 YR
• Patient Sex: Female