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

Model Number	QC-8-30-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil would not detach with an instant detacher or using manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The patient underwent coiling treatment for a ruptured saccular aneurysm.The vessel was observed severely tortuous.It was reported that the complaint coil was the 7th coil, in that case.Prof.Felber tried to detach the coil with the id detacher, it was not possible.Than he tried the emergency release at the end of the pushwire, that also didn't work.The physician attempted to detach the coil three times with instant detacher and one time with using manual method, but coil did not detach.The physician removed the coil and tried another on with a new detacher, that went well.Reported device and any accessory devices were prepared as indicated in the ifu.The patient died, and cause of death is massive ihb.Coiling was a try to get the situation better, but it was too massive.Patient date of death: asked and will not be made available (legal/confidential reason) headway 17, tracxess 14, instant detacher was discarded.
Additional Manufacturer Narrative
Device available for evaluation - additional information date mfr rec ¿ additional information type of follow up - device evaluation device evaluated by manufacturer- additional information codes updated the device was returned for evaluation and the clinical observation could not be confirmed.As received, the axium pushwire was returned without implant coil attached to the pushwire.The implant coil and instant detacher were not returned for evaluation.The pushwire was separated distal to the break indicator with the release wire extending out proximal end.It appears that manual detachment was attempted at this location.The actuator interface, coupler tube, positive load indicator and break indicator were missing not returned with the pusher for analysis.Additionally, kinks and bends were found on the proximal end of the pushwire.The coin was found to be present and pushed up against the lumen stop; with the shield coil present and stretched.The coin was damaged during investigation when the outer jacket was removed, and the release wire was pulled back leaving a part of the coin stuck within the lumen stop.The lumen stop and the retainer ring were found to be visually acceptable.Based on the analysis performed, we were unable to determine the cause of non-detachment of the implant coil.The implant coil, actuator interface, coupler tube, positive load indicator, break indicator and instant detacher were not returned; therefore, any contribution of the implant coil, actuator interface, coupler tube, positive load indicator, break indicator and instant detacher to the non-detachment could not be determined.Per the axium coil instructions for use (ifu): if the coil does not detach after 3 attempts, discard the i.D.(instant detacher) and replace with a new i.D.(instant detacher).Also, ¿in the rare event that the coil does not detach and cannot be removed from the implant delivery pusher, use the following steps for detachment.A.Grip the hypotube approximately 5 cm distal of the positive load indicator at the hypotube break indicator and bend the implant delivery pusher just distal to the hbi 180 degrees.B.Next straighten the pusher back, continue bending and straightening until the pusher tubing opens exposing the release element.C.Gently separate the proximal and distal ends of the open pusher.Then, under fluoroscopy, pull the proximal portion of the implant delivery pusher approximately 2-3 cm to confirm implant detachment per ifu.¿ 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: BARE AXIUM 3D COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8471956
• Report Number: 2029214-2019-00270
• Device Sequence Number: 13893479
• Product Code: KRD
• UDI-Device Identifier: 00836462010437
• UDI-Public: 00836462010437
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/19/2019

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: 08/06/2021
• Device Model Number: QC-8-30-3D
• Device Catalogue Number: QC-8-30-3D
• Device Lot Number: A688672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1