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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
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
Medtronic received information regarding a concerto coil that detached prematurely.It was reported that the device was inspected and prepared according to the manufacturer instructions for use with no issue identified.The coil detached during the procedure before the instant detached was used.The physician used a snare to successfully remove the coil and it was replaced.The patient did not sustain any harm or injury.
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 the device was returned for evaluation and the clinical observation could not be confirmed.As received, the concerto coil returned with the implant coil still attached to the pushwire.There was not any damage found on the implant coil.The concerto coil pushwire was found broken proximal to the break indicator.The two segments were retained by the release wire.The concerto pushwire was found to be bent at multiple locations from the proximal end of the distal segment.The actuator interface was found securely attached to the coupler tube.There is no evidence of any detachment attempts using an instant detacher.The coin was present and against the lumen stop.Dried blood was found within the outer jacket.The shield coil was found intact.Detachment was then attempted by retracting the exposed release wire.Resistance was found with the release wire and the coin did not move out of the lumen stop.The outer jacket was removed, and the device was put into an ultrasonic cleaner to dissolve the dried blood.The release wire was retracted again, this time successfully retracting the coin out of the lumen stop and detaching the implant coil.No other anomalies were observed.Based on the device returned analysis, there was not any premature detachment issue found with reported device as implant coil still attached to pushwire.There was no malfunction of the pusher/implant coil or non-conformance to specification that may have contributed to the customer report of premature detachment.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: 10029416
• Report Number: 2029214-2020-00431
• Device Sequence Number: 14110637
• Product Code: KRD
• UDI-Device Identifier: 00847536013704
• UDI-Public: 00847536013704
• 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): 07/24/2020

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: 02/20/2021
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: A601110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/04/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1