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

Model Number	NV-3-8-HELIX
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that a rebar catheter marker was not visible, therefore the concerto coil was misplaced and failed po sitioning.The coil was not implanted at the intended location.No additional steps or surgical interventions required to remove or secure the coil.The device did not jump during deployment.The vessel was not damaged.The tip of the catheter was not under stress.The physician did rotate the delivery pusher during the procedure.The aneurysm did not rupture.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per ifu.Access to the vessel was inguinal.The access vessel diameter was 8mm.Vessel tortuosity was moderate.The event did not lead to or extent patient hospitalization.No treatment was give.No patient symptoms or complications were reported.
Additional Manufacturer Narrative
Event related to regulatory report#: 2029214-2022-01197.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.
Additional Manufacturer Narrative
Product analysis: as found condition: the pushwire was returned for evaluation inside of a biohazard bag and a shipping box.There was no coil returned with the pushwire.The event description, the coil was implanted at an unintended location.Visual inspection/damage location details: the pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire; indicative of manual detachment was attempted at this location.The ai and coupler tubing were present and intact; it appeared that the mechanical detachment was not attempted at this location.Kinks and bends were observed along the length of the pushwire.Testing/analysis: n/a.Conclusion: based on the analysis performed, the concerto coil was not confirmed to have "coil deployed at incorrect location".The root cause could not be determined.The returned pushwire was found to be damaged (kinks/bends).However the cause for damages could not be determined.There was no non-conformance to specifications identified that led to the reported issue.L 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: 15060053
• Report Number: 2029214-2022-01198
• Device Sequence Number: 20216204
• Product Code: KRD
• UDI-Device Identifier: 00847536033528
• UDI-Public: 00847536033528
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 08/17/2024
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: B251694
• 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: 07/02/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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: Male