MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA AXIUM 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	QC-2-4-3D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium implant coil pushwire was returned and found to be broken into 3 segments.The first segment was found to be kinked at ~4.1cm, broken at ~7.3cm from proximal end and broken at break indicator.The second segment was found to be bent at ~81.0cm from broken proximal end, kinked at ~115.2cm, ~130.5cm from broken proximal end and broken with release wire protruding from broken distal end ~145.0cm from broken break indicator.The third segment was found to be broken and kinked at ~34.0cm from distal end.The implant coil was found to be detached and not returned.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.It is likely that the damages to the axium implant coils occurred during the attempt to push the coils through the echelon-10 micro catheter against the reported resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an axium coil became stuck in the hub of a microcatheter.The devices were replaced with medtronic devices to complete the procedure.No patient injury was reported as a result of the event.The coils were reported to have been pushed smoothly out of the introducer sheaths and the sheaths were seated securely in the hub of the microcatheters.The coil was returned and the pushwire was observed to be separated.
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
It was noted that the devices were badly damaged due to them being stuck.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8495219
• Report Number: 2029214-2019-00323
• Device Sequence Number: 2594385
• Product Code: KRD
• UDI-Device Identifier: 00847536017399
• UDI-Public: 00847536017399
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 07/06/2021
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: A671857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR