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

Model Number	NV-6-20-HELIX
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
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 reporting a concerto coil failed to deploy and fractured.The procedure was to treat an endoleak.6 concerto coils were implanted successfully to complete the procedure.
Additional Manufacturer Narrative
Product analysis findings: the concerto pushwire was returned within its inner pouch; inside of a biohazard bag and a shipping box.There was no implant coil or catheter returned with the pushwire.Kinks and bends were found along the length of pushwire.The ai, coupler tubing, and positive load indicator were found to be missing.The pushwire was found broken at the break indicator (manual detachment location) with the release wire pulling back; indicative of manual detachment was attempted at this location.The break indicator was also found to be missing and not returned.The coin was not located against the lumen stop as it was missing.The coil shield was present and intact; but stretched.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 0.00262¿ 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 sp ecification (0.00455"+/- 0.00010").All other subassemblies appeared to be normal.No other anomalies were observed.No other anomalies were observed.Based on the analysis performed, the concerto coil was not confirmed to have "coil non-detachment" issue as the p ushwire was returned with the implant coil already detached.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was found broken at the manual detachment location with the release wire pulling back; subsequently causing the implant coil to detach from its pushwire.In addition, kinks and bends were found along the length of pushwire; indicative of vessel tortuosity.Since the ai, coupler tubing, break indicator, coin, implant coil and catheter were not returned; any contribution of the ai, coupler tubing, break indicator, coin, implant coil and catheter to the non-detachment issue could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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: 10888985
• Report Number: 2029214-2020-01168
• Device Sequence Number: 3005635
• Product Code: KRD
• UDI-Device Identifier: 00847536033573
• UDI-Public: 00847536033573
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 09/30/2023
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: B094307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1