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

Model Number	FC-5-15-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that one coil detached prematurely, and another coil was stuck in the sheath.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the anterior cerebral artery (aca) a1 with a max diameter of 7-7.5 mm and a 3-3.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that all devices were prepared per the instructions for use (ifu).The fc-5-15-3d coil pre-detached in the microcatheter regardless of the physician.During the same procedure, an apb-3-8-3d-es coil was used with the intent to access the microcatheter to the a1 segment.However, the coil did not pass the microcatheter sheath.Replacement products were used to complete the procedure.There was no injury to the patient as a result of the event.Ancillary devices include a prowler 17 microcatheter.
Additional 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 or Problem Description
Additional information received reported that there was no kink/damage observed to the pushwire.
Additional Manufacturer Narrative
H3.Product analysis findings: the axium framing coil was returned for evaluation within the outer carton; inside of a biohazard bag and a shipping box.There was no pushwire or catheter returned with the coil.The implant coil appeared to be detached from the pushwire.The implant coil was found to be damaged and stretched with the polypropylene filament intact.The detached element was missing and not returned.Based on the analysis findings, the axium framing coil was confirmed to have ¿premature detachment¿ issue as the returned axium framing coil was found detached from the pushwire.The implant coil was damaged and stretched.However, the root cause and cause for damage could not be determined.Since the detached element and pushwire were not returned; any contribution of the detached element and pushwire to the premature detachment issue could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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.

• Brand Name: AXIUM FRAMING COIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11555024
• Report Number: 2029214-2021-00328
• Device Sequence Number: 3829787
• Product Code: KRD
• UDI-Device Identifier: 00847536034181
• UDI-Public: 00847536034181
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2021

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: 06/13/2023
• Device Model Number: FC-5-15-3D
• Device Catalogue Number: FC-5-15-3D
• Device Lot Number: B040011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 06/08/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1