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

Model Number	QC-2-8-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after the echelon-10 microcatheter was in place, an axium coil was used for the first coil for embolization, and the axium coil was detached after it successfully reached the position.When entering the axium coil, the resistance was very high.It was pushed several times, but the resistance was still very high.After the axium coil was withdrawn from the body, it was found that the distal end of the push rod was kinked and the proximal end was broken and the spring coil was detached outside the body.The coil was replaced and successfully entered and detached.The operation was successfully completed.The axium and any accessories were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for a gastric vascular bleeding treatment.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information was received that catheter resistance occurred in the proximal section.The coil did not come out of the introducer sheath smoothly.It was noted that the coil detached in vitro.Additional information was received that during the operation, the spring coil was not in place and no detachment was performed, and felt a lot of resistance when pushing.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
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
Product analysis #(b)(4): as found condition: the axium pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and within an introducer sheath.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube and the break indicator was found intact/unbroken.There is no indication of detachment attempts at these locations using an instant detacher or by manual method.The axium pusher was found bent at ~68.5cm from the proximal end and found kinked within the introducer sheath at ~146.1cm from the proximal end.The pusher was found broken at 47.0cm from the distal end with the two segments retained by the release wire.The coin was found fully retracted out of the lumen stop.The shield coil was found intact with the implant coil already detached.The axium implant coil was not returned for analysis.The retainer ring was found undamaged.Testing/analysis: n/a conclusion: based on the analysis performed, the customer report of ¿coil resistance/stuck in catheter¿ was confirmed as the confirmed ¿pusher kink/damage¿ is consistent with resistance.It is possible the damage occurred during the attempt to push the coil into the micro catheter against the reported resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damage to micro catheter, or tortuous anatomy.Customer reported devices were prepared per ifu and vessel tortuosity as normal.As no other information was provided, the cause cannot be determined.The customer report of ¿premature detachment" was confirmed.The cause of the detachment was due to the break found on the pusher.The release wire was found retracted and the coin was pulled out of the lumen stop, detaching the implant coil.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance, pusher damage, or premature detachment could not be determined.The echelon-10 is compatible for use with the axium coil.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: AXIUM HELIX
• 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: 18107901
• Report Number: 9612164-2023-05140
• Device Sequence Number: 5698651
• Product Code: KRD
• UDI-Device Identifier: 00847536037304
• UDI-Public: 00847536037304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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): 12/07/2023

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: 01/13/2026
• Device Model Number: QC-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: 225790092
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female