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

Model Number	NV-9-30-HELIX
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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 regarding a concerto coil that detached prematurely after failing to detach during detachment attempts.The patient was undergoing a procedure for coil embolization of the celiac artery and distal graft to treat an aortic aneurysm in the descending aorta involving the celiac artery.Blood flow was normal.Vessel tortuosity was minimal.The doctor decided to use the concerto 9 x 30 coil.It was noted that all devices were prepared as indicated in the instructions for use (ifu).After the coil was deployed in the celiac artery, the doctor tried twice to detach the coil using manual method but the coil did not fully detach.No attempt was made to detach the coil with an instant detacher.The coil pulled back with the detach wire.After this occurred, the coil detached in the abdominal aorta but was successfully removed.A competitor's device was then used to complete the procedure.It was indicated that there was no patient symptoms or injury associated with the event.
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 indicated there were no issues encountered prior to the coil non-detachment: the coil was deployed p erfectly.After removal of the pushwire, there was no damage observed.The coil was explanted by using a snare to retrieve the deployed coil.

• 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: 11202828
• Report Number: 2029214-2021-00072
• Device Sequence Number: 16872686
• Product Code: KRD
• UDI-Device Identifier: 00847536013766
• UDI-Public: 00847536013766
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 07/16/2021
• Device Model Number: NV-9-30-HELIX
• Device Catalogue Number: NV-9-30-HELIX
• Device Lot Number: A677113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 56