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

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that a concerto coil did not detach.The devices were prepared according to instructions for use (ifu). the product was being used as per the ifu but the coil did not detach from its wire (both manual method and detacher were tried several times).A new medtronic device was used to complete 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.
Additional Manufacturer Narrative
H3: as found condition: the concerto coil was returned for analysis within a shipping box; and within a plastic bio-pouch.There was no instant detacher returned with the device.Visual inspection/damage location details: the concerto implant coil was returned within the introducer sheath.No damages or irregularities were found with the introducer sheath.The actuator interface was securely attached to the coupler tube.No damage or irregularities were found with the actuator interface, break indicator or the rest of the pusher.No evidence of mechanical detachment using an instant detacher or manual detachment by breaking the break indicator were found.The concerto pushiwre was appeared to be bent at ~38.5cm and ~104.0cm from proximal end.The concerto implant coil was found damaged within the introducer sheath.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.No other anomalies were observed.Testing/analysis: the coil could not be pulled out of the introducer sheath as it was found to be stuck.A mechanical detachment was attempted using an in-house instant detacher, however the device failed to detach.A manual detachment was then attempted by breaking the break indicator and retracting the release wire, successfully detaching the device with no issues and no resistance encountered.Conclusion: based on the analysis performed, the concerto coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached.However, the cause could not be determined.The device failed to detach using an in-house instant detacher; however, breaking the break indicator, the alternative method given in the instruction for use, was successful in detaching the implant coil.The implant coil was found damaged.Possible causes for coil damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its defensive dispenser coil.There was no malfunction of the device or non-conformance to specification identified that led to the non-detachment.Since the instant detacher was not returned, any contribution of the instant detacher to the non-detachment could not be determined.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: 13972045
• Report Number: 2029214-2022-00542
• Device Sequence Number: 4792358
• Product Code: KRD
• UDI-Device Identifier: 00847536033504
• UDI-Public: 00847536033504
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 01/11/2024
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: B143994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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