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

Model Number	NV-10-30-HELIX
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coil did not widen and the pusher remained hanging.It was reported that during an embolization of pelvic varicose veins, healthcare provider (hcp) encountered a problem in the release of the coil: the coil did not widen.The pusher remained hanging.It was unknown if there was any assessment for product/therapy/procedure relatedness made by the investigator, sponsor, or clinical events committee (cec).It was unknown if there was any impact to the patient or any additional medical intervention required to prevent permanent injury or impairment.There were no patient symptoms/injuries related to this event.
Additional Manufacturer Narrative
Continuation of d10: product id id-1-5 (lot: unknown); 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.
Additional Manufacturer Narrative
B5: additional information added to event summary.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.
Event or Problem Description
Additional information received.¿the coil did not widen¿ was clarified to mean that ¿drop¿ is more appropriate.The procedure was completed by using another device.The report that the pusher remained hanging was clarified as referring to premature coil detachment.The pusher was not stuck in the instant detacher.No causes or contributing factors for the event were identified.There were no attempts to detach the coil using the instant detacher because the coil detached prematurely, and no attempts were made using the manual method.No issues were encountered prior, and no pushwire damage was observed after removal from the patient.
Event or Problem Description
Additional information received.It was clarified that ¿drop¿ means ¿tapered¿.Prior to coil premature detachment, no issues were en countered.The coil was removed from the patient.The coil prematurely detached in the catheter.The catheter model and lot number are unknown.The patient¿s vessel tortuosity was normal.No causes or contributing factors for the premature detachment were identified.
Additional Manufacturer Narrative
B5: additional information added to event summary.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: 24746928
• Report Number: 9617601-2026-02164
• Device Sequence Number: 8744114
• Product Code: KRD
• Combination Product (Y/N): N
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: 232594371
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/30/2026; 05/11/2026; 08/18/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/07/2026; 05/18/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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
• Patient Sex: Unknown