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	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a haemorrhoid artery embolization procedure, multiple issues were encountered with 4 concerto coils.The coil wires were very hard to advance during insertion into the microcatheter.Resistance was encountered in the catheter hub for the first 3 coils (nv-2-6-helix, nv-3-8-helix, and nv-3-8-helix), and did not push smoothly out of the introducer sheath as well.There was no damage to the catheter or the first 3 coils.The nv-4-10-helix coil appeared to be stuck in the microcatheter, was pushed forward, and some coil remained in the patient after removal of the coil wire, indicating coil separation/break/premature detachment.It was noted that the coil was implanted in the intended location, and no medical/surgical intervention was required.The pushwire was not bent or broken.It was contradictorily stated that there was no friction or difficulty during delivery.The physician did not reposition the coil, rotate the delivery pusher, or attempt to detach the coil.A continuous flush was not administered during the procedure.All devices and accessories were prepared as indicated in the instructions for use.The patient's blood flow and vessel tortuosity were normal.No patient complications have been reported as a result of this event.Ancillary devices include a boston truselect microcatheter.
Additional Manufacturer Narrative
Continuation of d10: product id nv-2-6-helix (lot: 231357138); product type: ; implant date n/a; explant date n/a product id nv-3-8-helix (lot: 231394867); product type: ; implant date n/a; explant date n/a product id nv-3-8-helix (lot: 231394867); product type: ; implant date n/a; explant date n/a.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 physician did not report resistance for the nv-4-10-helix coil despite report that the coil broke and appeared to be stuck in the catheter.The cause of the issues was unknown.
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.

• 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: 23476827
• Report Number: 9617601-2025-02512
• Device Sequence Number: 13386807
• Product Code: KRD
• UDI-Device Identifier: 00847536044920
• UDI-Public: (01)00847536044920(17)280618(10)231623987
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/26/2025

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-4-10-HELIX
• Device Catalogue Number: NV-4-10-HELIX
• Device Lot Number: 231623987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/26/2025
• Date Device Manufactured: 06/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown