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

Model Number	NV-3-8-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
There was no instant detacher returned with the concerto coil.The implant coil appeared to be stretched; but still attached to its pushwire.The pushwire appeared to be bent at 28.0cm from the proximal end.The ai to release wire crimps, coupler to ai crimps, and coupler to pusher tube weld are present and intact; it appeared that the mechanical detachment was not attempted.The break indicator at the manual detachment was still intact; it also appeared that the manual detachment was not attempted at this location.The coin was located against the lumen stop.The shield coil was present and intact; with no damage.The concerto coil was then successfully detached on the first attempt using an in-house instant detacher.Under the microscope, the outer jacket was then removed to gain access the coin.No damage was found with the coin.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00260¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured to be 0.00460¿and found to be within specification (0.00455"+/- 0.00010").All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the concerto coil was confirmed to have ¿non-detachment¿ issue as the returned coil was still attached to the pushwire.However, the root cause could not be determined as the returned concerto coil was successfully detached on the first attempt using an-house instant detacher.There was no mechanical or manual detachment attempt was found on the returned concerto coil.In addition, the pushwire was found to be bent; and the implant coil was found to be damaged and stretched.However, the cause for damages could not be determined.There was no non-conformance to specifications identified that lead to the non-detachment issue.Since the instant detacher was not returned; therefore, any contribution of the instant detacher to the non-detachment issue could not be assessed.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 NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10187048
• Report Number: 2029214-2020-00586
• Device Sequence Number: 3016483
• Product Code: KRD
• UDI-Device Identifier: 00847536013391
• UDI-Public: 00847536013391
• 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): 09/25/2020

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: 10/21/2021
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: A727512
• 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: 09/23/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1