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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
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 a report that the concerto coil would not detach.A different instant detacher and manual detachment were not attempted.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received reporting that detachment with the instant detacher was attempted only once.Prior to non-detachment, there were no issues or difficulties in the procedure.There was no observed damage to the pusher.
Additional Manufacturer Narrative
The concerto implant coil was returned without the introducer sheath.The actuator interface was securely attached to the coupler tube.No damage or irregularities were found with the actuator interface, break indicator or the rest of the pusher.No evidence of mechanical detachment using an instant detacher or manual detachment by breaking the break indicator were found.The concerto implant coil was found damaged.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.A mechanical detachment was attempted using the returned instant detacher, and retracting the release wire, successfully detaching the device with no issues and no resistance encountered.No other anomalies were observed.During evaluation, the instant detacher was taken apart to evaluate the components.All components appeared to be normal.The surface around the bottom inner diameter of the instant detacher cap appeared to be clean.The instant detacher cap inner diameter was measured to be 0.0140¿ with visual inspection system.The instant detacher was found to be within specifications (0.0140¿ + 0.0005¿/-0.0005¿).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 could not be determined.The device was successful in detaching the implant coil using the returned instant detacher.The implant coil was found damaged.Possible causes for coil damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its defensive dispenser coil.There was no malfunction of the device or non-conformance to specification identified that led to the non-detachment.There is no indication that the event is related to a potential manufacturing issue.Based on the analysis findings, the customer report of ¿unable to detach¿ could not be confirmed.The event cause could not be determined.The returned instant detacher was used to successfully to detach returned concerto implant coil on the first attempt without any difficulty.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: 10204059
• Report Number: 2029214-2020-00605
• Device Sequence Number: 14106644
• Product Code: KRD
• UDI-Device Identifier: 00847536013704
• UDI-Public: 00847536013704
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2020

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: 10/30/2021
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: A732972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 09/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/07/2020; 09/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1