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

Model Number	NV-5-15-HELIX
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition- the concerto device was returned for analysis within a shipping box, within a tyvek biohazard pouch, within a sealed plastic biohazard pouch, within its opened concerto inner pouch and within a resealable plastic biohazard pouch.Two other concerto devices were also returned and will be addressed in pli-20 and pli-30.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found broken and the release wire was also found broken.The distal pusher and implant coil were not returned for analysis.Testing/analysis ¿ n/a conclusion - based on the customer report and device analysis, the customer report of "non-detachment" and ¿difficulty with hypotube break¿ were confirmed.The release wire was found broken.It is possible the break in the release wire lead to the distal release wire failing to retract, causing the reported non-detachment.The cause of the release wire break could not be determined.As the distal pusher and implant coil were not returned, any contribution of the pusher (and other detachment subassemblies) and implant towards the non-detachment could not be assessed.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 two 20 mm concerto coils would not detach due to filament break, and one 15 mm concerto coil would not detach when it broke at its end.The patient was treatment for a gastrointestinal bleed.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the two 20mm concerto coils would not detach because the filament in the detachment filament broke at hypo tube break indicator when attempting to manually detach the coils.There was not enough filament exposed to manually pull to detach the coils.The coils were removed without complication and no resistance occurred in the non-medtronic catheter during delivery or positioning.The concerto coil 15mm coil would not detach manually.This physician/account typically does not use the instant detacher.They prefer to manually detach coils.After these three coils did not deploy successfully, they went on to use several more concerto coils without complications.The physician did not attempt to detach using any instant detacher.Instead, there was a single manual attempt at detachment.Prior to coil non-detachment, no issues were encountered.No push wire damage was observed after removal from the patient.The event cause was not determined.There was no issue with the instant detacher.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received.The cause of the event was not determined, and there was no friction or difficulty during delivery or positioning.No resistance was encountered in any section of the catheter.The catheter was flushed according to the ifu, but it was not a medtronic product.The defect with the concerto coil was that the manual break detachment did not work; no instant detacher was used.No issues were encountered prior to the coil non-detachment, and no pushwire damage was observed after removal from the patient.Ancillary devices include a microcatheter: terumo 2.4fr progreat.

• 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: 24640274
• Report Number: 9617601-2026-01902
• Device Sequence Number: 15899330
• Product Code: KRD
• UDI-Device Identifier: 00847536044937
• UDI-Public: (01)00847536044937(17)280113(10)230458066
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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-5-15-HELIX
• Device Catalogue Number: NV-5-15-HELIX
• Device Lot Number: 230458066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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 Age: 67 YR
• Patient Sex: Male