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

Model Number	NV-2-6-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id nv-2-4-helix (lot: 231316177); product type: ; implant date n/a; explant date n/a product id nv-2-6-helix (lot: 231221824); 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
Medtronic received a report that nv-2-4-helix (batch no: 231316177) was discovered kinked upon opening the package.There was pusher kink/broken.The damaged location was the pushwire middle segment.Another coil nv-2-6-helix (batch no: 231221824) was unable to deploy.There was non-detachment.The physician attempted to detach the coil with the instant detacher two times.The physician tried to detach with another instant detacher.There was one manual attempt at detachment via hypotube.There was no issue with the instant detacher.Another coil nv-2-6-helix (batch no: 231221824) was discovered kinked upon opening.There was pusher kink/broken.There was no friction or difficulty during testing or delivery.The continuous flush was administered during the procedure.The damaged section was the pushwire middle segment.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient is alive with no injury.The patient was undergoing surgery for treatment of an aneurysm.Ancillary devices include a terumo sheath, boston truslect microcatheter.
Additional Manufacturer Narrative
Product analysis as found condition- all three concerto devices were returned for analysis within a shipping box, inside of a plastic biohazard bag, all inside individual opened concerto outer cartons, opened concerto inner pouches, with 2 devices within a resealed able plastic bag, and with pli 10 within a dispenser coil.No microcatheter was returned.Visual inspection/damage location details ¿ the introducer sheath was found to be 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 secure within the pushwire coupler tube.No visual ware or damage was found with the actuator interface; therefore, unable to confirm a detachment attempt with an instant detacher.A kinked was found distal to the break indicator, indicative of a manual attempt to detach the implant coil (3tack weld broken).The pushwire was found to be bent at ~32.7cm and bent at ~55.4cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath at ~111.8cm, kinked at ~33.4cm and kinked (damaged) at ~18.8cm from the distal end.The concerto implant coil was returned still attached to the pushwire; however, the implant coil was found to be damaged within the introducer sheath.The coin was found to be in good condition still against the lumen stop.No damage or irregularities were found with the lumen stop or the retainer ring.No other anomalies were observed.Testing/analysis ¿ during testing, the coin was found in good condition and measured to be ~0.065mm @ 0.063mm, ~0.081mm @ 0.127mm, and ~0.086mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).Next, an in-house instant detacher was used in an attempt to detach the concerto device, which successfully worked without any issues.The concerto implant coil was able to be detached from the pushwire on the first attempt.The release wire was able to move freely within the pushwire coupler tube.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was able to be confirmed; however, the root cause of ¿non-detachment¿ cannot be determined.No ¿non-detachment¿ was able to be reproduced.During testing, an in-house instant detacher was able to detached the concerto implant coil first try without any issues.The coin was found against the lumen stop in good condition.A possible cause of non-detachment is but not limited to ¿damaged pusher¿; however, no root cause was able to be determined.The concerto detach subassemblies worked as intended.The report notes that ¿there was one manual attempt at detachment via hypotube.¿, which was able to be confirmed, as a bend/kink was found distal of the break indicator.The instant detachers used in the procedure was not returned for assessment; therefore, any contribution the detachers had towards the non-detachment was able to be confirmed.The non-medtronic device (truslect microcatheter) was not returned; therefore, any contribution the microcatheter had towards the detachment was unable to be assessed.The truslect microcatheter was found to be compatible with the concerto device.No mention of the patient's blood flow and vessel tortuosity was reported.The continuous flush was administered during the procedure.The device and any accessories were prepared as indicated in the ifu.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: 23458266
• Report Number: 9617601-2025-02471
• Device Sequence Number: 7958177
• Product Code: KRD
• UDI-Device Identifier: 00847536044876
• UDI-Public: (01)00847536044876(17)280507(10)231221824
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 12/04/2025

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-2-6-HELIX
• Device Catalogue Number: NV-2-6-HELIX
• Device Lot Number: 231221824
• 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: 10/26/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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