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

Model Number	PV-18-40-3D
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	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that during a coiling procedure, the concerto coil was reported to have unintentionally detached when being inserted into the aneurysm.The coil was retrieved with a snare device.The procedure was completed with additional coils.No patient injury occurred.The devices were reported to have been prepared and used per the instructions for use.The vessel anatomy was severe.The coil was not repositioned.It is unknown if the pushwire was rotated during the advancement.A continuous flush was not maintained during the procedure.
Additional Manufacturer Narrative
The implant coil was returned only.There was no pusher, microcatheter, or accessories returned with the device.The implant coil appeared to be damaged and stretched; with the polypropylene broken and stretched.The detached element was not found on the returned implant coil.No other anomalies were observed.Based on the analysis performed, the concerto coil was confirmed to have prematurely detached.The returned implant coil found to be damaged and stretched.However, the cause for damage could not be determined.Since the pusher and detached element were not returned; any contribution of the pusher and detached element to the issue could not be determined.Per the concerto coil and i.D.(instant detacher) instructions for use (ifu): do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm.Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration.Do not use hemostats in an attempt to advance delivery pusher.This may result in a kinked pusher which may lead to 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: 8391273
• Report Number: 2029214-2019-00159
• Device Sequence Number: 19226518
• Product Code: KRD
• UDI-Device Identifier: 00847536026520
• UDI-Public: 00847536026520
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 09/11/2021
• Device Model Number: PV-18-40-3D
• Device Lot Number: A706495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1