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

Model Number	FC-3.5-8-3D
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an axium framing coil that detached prematurely.The patient was being treated for a ruptured aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 3.5mm.Vessel tortuosity was severe.It was reported that the axium coil was being used simultaneously with a competitor's coil.The axium framing coil was used for the first frame, and the competitor's coil for the second frame.The surgeon inserted the coil and pulled out several times.The axium coil was prematurely detached.The surgeon had not made any attempts to detach the coil when the issue occurred.The surgeon removed the axium coil and competitor's coil with a micro snare.Continuous catheter flush was provided during the procedure.The coil was discarded and replaced with a competitor's product.The patient developed a thrombus during the procedure while the prematurely detached coil was being pulled out.
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 difficulty positioning the coils and poor framing.There was no resistance or friction when the physician pulled the coil out, and no kink/damage was observed on the pushwire.It was unknown if the patient was currently symptomatic.

• Brand Name: AXIUM FRAMING COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10316899
• Report Number: 2029214-2020-00718
• Device Sequence Number: 2890141
• Product Code: KRD
• UDI-Device Identifier: 00847536034099
• UDI-Public: 00847536034099
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: FC-3.5-8-3D
• Device Catalogue Number: FC-3.5-8-3D
• Device Lot Number: A910954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/01/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other