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

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
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 report that the concerto coil did not performing as intended, as the coil was unable to detached.The device was prepared and used per the instructions (ifu).The anatomy was severe in tortuosity.The treating location was the prostate.
Additional Manufacturer Narrative
The concerto coil was returned without a dispenser coil and within an introducer sheath.The instant detacher was returned.The concerto coil was decontaminated.The actuator interface was securely attached to the coupler tube.No damages or irregularity was observed with the actuator interface, positive load indicator, coupler tube, break indicator, and crimps.There are no indications of any mechanical or manual detachment attempts at these locations.No damages or irregularities were found with the rest of the pusher.The implant coil was found to still be attached to the pushwire but was returned pushed out of the introducer sheath with damages found on the implant coil.No damage was found with the introducer sheath.The coin was found to be present and pushed up against the lumen stop; with the shield coil present and intact.A mechanical detachment attempt was performed by using an in-house instant detacher.The implant coil was successfully detached with no issue on the first attempt.No other anomalies were observed.Based on the analysis performed, the concerto coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached, however, the cause cannot be determined, as there were no indications of mechanical or manual detachment being attempts.The failure could not be replicated as the implant coil was successfully detached with no issues using an in-house instant detacher.However, the implant coil was found damaged.Possible causes for coil damage are patient vessel tortuosity, advancing device against resistance or damaged during shipment as the device was returned without its defensive dispenser coil and deployed outside of its introducer sheath.There was no malfunction of the device or non-conformance to specification identified that led to the non-detachment.Since the instant detacher was not returned, any contribution of the instant detacher to the non-detachment could not be determined.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: 9401472
• Report Number: 2029214-2019-01182
• Device Sequence Number: 1725212
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: 00847536013346
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 05/20/2022
• Device Model Number: NV-2-8-HELIX
• Device Lot Number: A834968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1