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

Model Number	NV-10-30-HELIX
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.Healthcare provider information was not provided at the time of report 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 was not released and was damaged.The patient was undergoing surgery for treatment of the left gonadal veins in the distal section.It was noted the patient's vessel tortuosity was moderate.There was no calcification.The artery diameter was 9mm and length was 8mm.There were no abnormalities reported in related to anatomy.There was no medical or surgical intervention needed to prevent permanent impairment of a function.The event did not lead to or extend patient hospitalization and there was no injury.It was reported that the patient who was admitted for gonadal phlebography, underwent surgery for embolization.Coil concerto was used but it was not released.Another device was used and the procedure was able to end without any problems.It was noted that the coil was kinked in the middle section during second advancement and resistance was felt during withdrawal.The catheter gripped at the distal tip.The procedure was completed using another medtronic coil.The vessel was not pre or post dilated.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include an introducer 6f boston sheath and hydrophilic terumo guide 0.035x150.
Event or Problem Description
Additional information received clarified that the coil experienced resistance in the medial lumen of the catheter.The coil did not come out of the catheter sheath as it was trapped.No instant detacher was used and it was not possible to detach the coil because it was stuck in the catheter.The cable broke off the coil when trying to remove it from the catheter.The catheter used in the procedure was not manufactured by medtronic.
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.
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 received reported the coil could not be released, when trying to remove it from the catheter it was not possible since it was trapped inside the catheter.It was noted that everything happened inside the catheter.

• 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: 19982711
• Report Number: 9612164-2024-03709
• Device Sequence Number: 16834421
• Product Code: KRD
• UDI-Device Identifier: 00847536044999
• UDI-Public: 00847536044999
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/30/2024

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 Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: 228640132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 09/12/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/03/2024; 09/30/2024
• Date Device Manufactured: 04/11/2024
• 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: Female