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

Model Number	NV-3-4-HELIX
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	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto has not been returned for evaluation.The reported event could not be confirmed and the event cause could not be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that coil detached itself during preparation.No further details was provided.
Additional Manufacturer Narrative
A terumo 2.7f competitor catheter was returned.The terumo catheter was decontaminated.The terumo competitor catheter did not have apparent damages.The terumo competitor catheter was flushed, and water exited from the distal tip.An in-house mandrel was inserted into the terumo catheter hub and distal tip.The terumo catheter was found occluded at the proximal end of the hub.The terumo competitor catheter was dissected, and the concerto implant coil was removed from within the terumo catheter.The concerto implant coil was found damaged with the detachment element within the implant coil.The coil shell weld appears to be intact.The detachment element was then removed from the implant coil for evaluation.The detachment stick was found to be in good condition and the detachment ball was measured to be within specifications.The concerto pushwire was not returned.Therefore, analysis could not be performed and conformance to specification could not be assessed.No other anomalies were observed.The terumo competitor catheter will be sent to the manufacturer.Based on the device analysis and reported information, the report of ¿premature detachment¿ was confirmed.Premature detachment can be caused by tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance, or damaged pusher.However, there the exact cause for the reported event could not be determine.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: 9351865
• Report Number: 2029214-2019-01150
• Device Sequence Number: 13893903
• Product Code: KRD
• UDI-Device Identifier: 00847536013360
• UDI-Public: 00847536013360
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/17/2020

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: 10/11/2021
• Device Model Number: NV-3-4-HELIX
• Device Lot Number: A722933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1