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

Model Number	NV-10-30-HELIX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
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 during the procedure, the coil was broken.After removing the coil, the treatment was finished with a replacement product.It was unknown if the devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.No lesion or vessel characteristics were made available.
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 the kind of damage to the coil was unknown.There were no issues that resulted in the damage found, and a continuous flush was used during the procedure.It was unknown what kind of microcatheter was used with the coil.
Additional Manufacturer Narrative
H3: analysis of the concerto coil (model: nv-10-30-helix lot: b011912) found that the pushwire was kinked at 5.2 cm, bent at 31.8 cm, and kinked at 53.1 cm from proximal end.The concerto coil was found to be already detached.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.The distal outer jacket was removed, in order to measure the release wire.The coin was measured in 3 locations and found to be within specifications.At 0.063 mm the coin was measured to be 0.089 mm, at 0.127 mm it was measured to be 0.092 mm and at 0.275 mm it was measured to be 0.097 mm.The lumen stop inner diameter (id) was unable to be measured as it was found to be damaged.The retainer ring appeared to be in good condition and measured to be 0.0049 in which is not within specification.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil break/separation¿ was confirmed as the implant coil was already detached.Possible causes of coil break/separation are tortuous anatomy, coil advanced against resistance or coil is not retracted in a one to one motion with the implant pusher during repositioning.H6: method code updated to b01.Result code updated to c070601 and c070603.Conclusion code updated to d15.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
No additional information received.

• 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: 11167150
• Report Number: 2029214-2021-00051
• Device Sequence Number: 3501839
• Product Code: KRD
• UDI-Device Identifier: 00847536033610
• UDI-Public: 00847536033610
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2021

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: 04/20/2023
• Device Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: B011912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/22/2021; 03/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/02/2021; 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1