MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number FC-14-30-3D

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an axium framing coil that detached prematurely after failing to detach when attempted.The patient was undergoing a coil embolization procedure to treat an unruptured saccular right internal carotid artery (ica) aneurysm.It was noted that the patient had a remodeling stent previously implanted in the ica.However, the type of stent and when it was implanted was unknown.The aneurysm measured 20 x 13 x 11mm.Blood flow was normal.Vessel tortuosity was severe.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The first coil used in the procedure was delivered and deployed without issue.The complaint coil was the second to be used in the procedure.The coil failed to detach despite 4 attempts to detach with the instant detacher (id) and 2 attempts to detach by manual method with the hypotube.It was noted a second id was tried but the coil still failed to detach.Since the coil could not be detached, the surgeon decided to remove the coil.When removing the coil, it detached with part of the coil remaining in the aneurysm and part of the coil deployed in the cervical right ica.The catheter dropped to the location in the ica where the coil detached prematurely so the microcatheter was removed with the coil pushwire.The surgeon tried to access the aneurysm again with the echelon and avigo guidewire.However, due to the artery tortuosity and the coil that was deployed in the artery, the location could not be accessed and the surgery could not be continued.It was noted that the previously implanted stent may also have contributed to the difficulties during the procedure.There were no patient symptoms or other complications associated with the event; the patient was considered to be without injury.No additional medical or surgical intervention was needed to prevent permanent impairment.The event did not prolong the patient's hospitalization.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported no additional actions were required to secure the segment of the coil that was implanted outside the aneurysm in the patient vessel.There was no kink/damage observed on the coil push wire.Only one instant detacher was used.

• Brand Name: AXIUM FRAMING COIL
• Type of Device: 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15581955
• MDR Text Key: 307114044
• Report Number: 2029214-2022-01693
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K162704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC-14-30-3D
• Device Catalogue Number: FC-14-30-3D
• Device Lot Number: 223187270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/10/2023
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female