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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2020
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
It was reported the coil was being used as per the ifu, but the coil did not detach within the vessel.A new coil was used, and the procedure was successfully completed.The patient's status at the time of the report was alive-no injury.It was noted that the device and any accessory devices were prepared as indicated in the ifu.
Additional Manufacturer Narrative
D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation as received, the concerto coil returned with the implant coil still attached to the pushwire.The instant detacher used during the event was not returned.The actuator interface was securely attached to the coupler tube.There was no evidence of detachment using an instant detacher at this location.The break indicator was found intact.There is no evidence of a manual detachment perform at this location.The concerto pushwire was found bent at from the proximal end.The implant coil was returned partially deployed out of the distal end of the introducer sheath.The implant coil was found damaged and stretched with the polypropylene filament intact.The coin was found still against the lumen stop.The shield coil was found intact and the implant coil was still attached to the pusher.An in-house instant detacher was used for detachment testing.The implant coil detached on the first attempt with no issues.No other damages or abnormalities were observed.Based on the analysis performed, the report of ¿non-detachment¿ was confirmed as the device was returned with the implant coil still attached, however, the cause could not be determined.There was no evidence of detachment attempt using an instant detacher or by manual method by breaking the break indicator.In addition, the non-detachment could not be replicated during in-house testing as the device detached with no issue using an instant detacher.As the instant detacher used during the event was not returned, any contribution of the instant detacher to the non-detachment could not be determined.The pushwire was found bent and the implant coil was found damaged/stretched.Possible causes are patient vessel tortuosity, advancing the device against resistance, lack of hydration before procedure, user does not maintain continuous flush, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or incompatible catheter.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: CONCERTO COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10186992
• Report Number: 2029214-2020-00585
• Device Sequence Number: 19587212
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• 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): 08/01/2020

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: 03/10/2022
• Device Model Number: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: A796535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 06/20/2020
• Supplement Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1