MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-4-8-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	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving a concerto coil, the coil was not deployed due to resistance and it became stuck in the catheter.The patient outcome was reported as alive with no injury.No patient complications have been reported as a result of this event.Additional information was received that vessel tortuosity was moderate and the patient is alive with no injury.The device was prepared as indicated in the ifu.A new medtronic device was used to complete the procedure well.Catheter resistance occurred in the middle section.The coil came out of the introducer sheath smoothly.The catheter used was not a medtronic product.
Additional Manufacturer Narrative
H3: product analysis#: (b)(4): equipment used: vis m-81805, 203cm ruler m-83360 as found condition: the concerto implant coil was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, and within an opened concerto implant coil outer carton.No microcatheter was returned.Damage location details: the concerto implant coil was returned without the introducer sheath.The pushwire was found to be bent at ~1.3cm; broken at ~6.2cm (with the release wire possibly triggered); bent at ~53.6cm and bent at ~78.6cm from the proximal end.The concerto implant coil was found to be missing (not returned).No other anomalies were observed.Testing analysis: the concerto implant coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was unable to be confirmed, and the root cause could not be determined.The concerto implant coil was returned with the pushwire damaged and the implant coil missing.Advancing the implant coil against resistance may lead to possible damage; therefore, it is possible that the damage occurred when the customer attempted to advance the coil through the catheter against the resistance.Possible causes for resistance are but are not limited to, the use of an incompatible catheter, lack of hydration before the procedure, patient tortuous anatomy, and lack of continuous flush administered during the procedure.The device was prepared as indicated in the ifu.There was no report of a continuous flush at the beginning of the procedure, which could be a possible cause for resistance, due to the lack of hydration during the procedure; however, this could not be determined.The patient¿s vessel tortuosity was moderate with no information about the blood flow.The reported microcatheter used in the procedure was a non-medtronic device and was not returned for further assessment; therefore, compatibility was unable to 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): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21692102
• Report Number: 2029214-2025-00771
• Device Sequence Number: 18496586
• Product Code: KRD
• UDI-Device Identifier: 00847536044913
• UDI-Public: 00847536044913
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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-4-8-HELIX
• Device Catalogue Number: NV-4-8-HELIX
• Device Lot Number: 227920952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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