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

Model Number	NV-9-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the concerto coil was returned for analysis within a shipping box, an opened concerto outer carton (222711308), and an opened concerto inner pouch (222711308).Damage location details: the concerto pusher was found broken at 6.0cm from the pusher proximal end with the release wire pulled.The implant coil was found detached from the pusher within the introducer sheath.No damages were found with the introducer sheath.The implant coil was found to be in good condition within the introducer sheath.Testing/analysis: the concerto implant coil was pushed out from within the introducer sheath without issue.Conclusion: based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in sheath¿ report could not be confirmed.No damages were found with the concerto implant coil.In addition, the concerto implant coil was pushed out from within the introducer sheath without issue.Resistance can occur if the rhv is overtightening of rhv or the introducer sheath is not properly seated within the catheter hub.However, the cause of the reported resistance could not be determined.Regarding the damage to the concerto pusher (broken) and the detachment of the implant coil.The implant coil can become detached if the pusher is broken and the release wire is pulled.However, the cause of the pusher damage 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.
Event or Problem Description
Medtronic received a report that the concerto wouldn't deploy into the sheath.Another coil was opened and used.No additional information was known at this time.

• 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: 19696257
• Report Number: 2029214-2024-01190
• Device Sequence Number: 20849664
• Product Code: KRD
• UDI-Device Identifier: 00847536044982
• UDI-Public: 00847536044982
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 07/08/2024

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 Expiration Date: 08/05/2024
• Device Model Number: NV-9-30-HELIX
• Device Catalogue Number: NV-9-30-HELIX
• Device Lot Number: 222711308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/08/2024
• Date Device Manufactured: 08/05/2021
• 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