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

Model Number	NV-10-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil was returned within the introducer sheath.The axium coil was found to be inverted within the introducer sheath with the implant coil within the ¿wave-lock¿ portion of the introducer sheath.The pusher was found to be kinked at ~ 3.2cm from the proximal end.No damages were found with the introducer sheath.The implant coil was found to be broken from the distal end and not returned for analysis.No other anomalies were observed.The concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.Advancing the concerto coil against resistance would result in damage to the implant coil subsequently causing the implant coil to break off from the pusher.The concerto implant coil was broken off the distal end and not returned for analysis.In addition, the pusher was returned kinked.The concerto coil can become damaged if advanced against resistance.It is possible that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.Possible causes of resistance include the use of a damaged catheter, incompatible catheter, lack of hydration before the procedure, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.Information regarding the device being prepared according to the instructions for use (ifu), the use of a continuous flush and the patient¿s vessel tortuosity was not provided.The model and lot numbers for the microcatheter used in the event were not provided; therefore, compatibility could not be assessed.Since the catheter was not returned, an analysis could not be performed.The cause for the reported resistance 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.
Event or Problem Description
Medtronic received a report that the concerto coil was stuck in the microcatheter. the device was replaced, and the patient did not experience any injury.Additional information received reported the cause of the event was the coil was stuck in the catheter.The coil came out of the introducer sheath smoothly.The catheter was not a medtronic product.
Additional Manufacturer Narrative
H3: the concerto coil was returned within the introducer sheath.The axium coil was found to be inverted within the introducer sheath with the implant coil within the ¿wave-lock¿ portion of the introducer sheath.The pusher was found to be kinked at ~ 3.2cm from the proximal end.No damages were found with the introducer sheath.The implant coil was not returned for analysis.No other anomalies were observed.The concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was not conf irmed as the coil appeared to be prematurely detached from the pusher.The cause 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: 15821175
• Report Number: 2029214-2022-01959
• Device Sequence Number: 11528773
• Product Code: KRD
• UDI-Device Identifier: 00847536044999
• UDI-Public: 00847536044999
• 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): 05/11/2023

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: 12/17/2024
• Device Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: 223518218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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