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 Codes	Use of Device Problem (1670); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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 coil could not be deployed (non-detachment) by back up method and the release element was exposed.The physician attempted to detach the coil with the instant detacher 1 time.They did not try to detach with another instant detacher.There were 2 manual attempts at detachment via hypotube.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were reported.
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 in order to resolve the non-detachment issue, the device was replaced with another nv-8-30-helix.In clarifying the previous report of "release element was exposed," it was noted that the physician bent the hypotube and the release wire exposed but the coil was not deployed.The cause of the non-detachment was not determined.Prior to coil non-detachment, no issues were encountered.No pushwire¿damage was observed after removal from the patient.Patient's vessel tortuosity was normal.The patient experienced no symptoms related to the non-detachment.The information is confirmed by the physician.
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: vis (m-78210), 203cm ruler (m-83361) document used: n/a as found condition (condition of returned device): a concerto implant coil was returned within a shipping box; within a sealed biohazard pouch; within an opened concerto implant coil inner pouch and within a dispenser track.The concerto implant coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface was found to be missing and not attached to the coupler tube.There appeared to be evidence of manual detachment.The concerto pushwire was found to be broken distal to break indicator and bent at ~3.5cm from broken proximal end.The coin was found not against the lumen stop and removed from pushwire assembly.The shield coil was found intact with the implant coil already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): the distal outer jacket was removed.The retainer ring was found to be visually in good condition and the inner diameter was unable to be measured accurately.Conclusion: based on the analysis performed, the concerto coil was unable to be confirmed to have non-detachment as the pushwire was returned with the implant coil already detached.The root cause could not be determined.The pusher was found to be bent/kinked.Possible causes for pusher damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its dispenser coil.Since the instant detacher was not returned, any contributing factors of the instant detacher to the non-detachment could not be determined.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: 22045690
• Report Number: 9617601-2025-00478
• Device Sequence Number: 21080292
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: (01)00847536044975(17)280128(10)230576064
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 07/21/2025

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-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 230576064
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 06/24/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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