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

Model Number	NV-6-20-HELIX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
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 that a concerto coil detached prematurely.The patient was being treated for a gastrointestinal bleed.Patient blood flow and vessel tortuosity was normal.The devices were prepared according to the instructions for use (ifu). the coil self deployed.It was still in the sheath and removed from the patient.No medical or surgical intervention was required.There was no friction or difficulty during deployment.The physician did not reposition the coil.Continuous flush was administered during the procedure.No symptoms were reported.
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
During preparation, the introducer sheath was held at an angle when the implant coil was pulled back inside during hydration, not sure if vertical.
Additional Manufacturer Narrative
H3.Product analysis.Equipment used: vis (m-81805), 203cm ruler (m-83360).As found condition: the coils were returned for analysis within a shipping box and within a plastic bio-pouch.It could not be determined which coil corresponds to each pli.Visual inspection/damage location details: multiple devices were returned with one device returned in a condition that presented the alleged issue.The analysis of the device found the following: the coil was returned without its introducer sheath.The pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.The pusher and release wire were found broken at ~42.3cm from the pusher distal end and retained by the inner liner.The release wire coin was found pulled back from lumen stop, the shield coil was intact, and the implant coil was found detached from the pusher.The implant coil was not returned.The shield coil was removed, the release wire distal tip was not extending out from the distal end of the pusher.The release wire was removed from the pusher.The release wire coin was found in good condition.The pusher lumen stop and retainer ring were found in good condition.Conclusion: based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in sheath¿ and ¿premature detachment¿ reports could not be confirmed as it could not be determined which coil corresponds to each pli.Resistance in sheath can occur due to damage during preparation or due to improper hubbing technique.However, the cause for the resistance could not be determined.Premature detachment can occur due to 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, damaged pusher, and damage to retainer ring.However, the cause for the premature detachment could not be determined.H6.Coding updated based on analysis results.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, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14079459
• Report Number: 2029214-2022-00613
• Device Sequence Number: 19363542
• Product Code: KRD
• UDI-Device Identifier: 00847536033573
• UDI-Public: 00847536033573
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2022

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: 12/08/2024
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: B309679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/07/2022; 06/06/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/06/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown