MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-3-4-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
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 have not 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 axium coil could not be detached during delivery.The physician did not use an instant detacher.The physician did try 3 manual attempts via hypotube to detach the coil.The axium coil 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 treatment of a saccular, unruptured anterior cerebral communicating artery segment aneurysm with a max diameter of 3.5mm and a 2.3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal. ancillary devices include a cook 6 sheath, navien 5f guide catheter, echelon10 microcatheter, and a synchro2 guidewire.
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
Additional information received that there was no pushwire damage observed after removal from the patient.
Additional Manufacturer Narrative
H3: product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the axium pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a sealed tyvek biohazard pouch and within a dispenser coil.The echelon-10 micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.There was no evidence of detachment attempts using an instant detacher at this location.The break indicator was found broken with the two segments retained by the release wire.This is indicative of a manual detachment attempt.No damages or irregularities were found with the remaining pusher.The coin was found fully retracted out of the lumen stop.The coin was found undamaged.The shield coil was found undamaged.The lumen stop was found undamaged.The implant coil was already detached and not returned for analysis.Testing/analysis: the inner diameter of the lumen stop was measured to be 0.00281¿, which was within specification (specification: 0.00220¿ ¿ 0.0029¿).The coin was measured to be ~0.089mm @ 0.063mm, ~0.090mm @ 0.0127mm, and ~0.091mm @ 0.0275mm; which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.0105mm @ 0.0127mm; and 0.086mm ¿ 0.0108 @ 0.0275mm) no other anomalies were observed.Conclusion: based on the analysis performed, the customer report of ¿non detachment" could not be confirmed as the device was returned with the implant already detached.There were no non-conformances found with the specifications or irregularities found that would contribute towards a non-detachment.As the implant coil was not returned for analysis, any contribution of the implant towards the non-detachment could not be assessed.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: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17930839
• Report Number: 9612164-2023-04660
• Device Sequence Number: 6426008
• Product Code: KRD
• UDI-Device Identifier: 00847536037687
• UDI-Public: 00847536037687
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024

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: 09/20/2025
• Device Model Number: QC-3-4-3D
• Device Catalogue Number: QC-3-4-3D
• Device Lot Number: 225113045
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 12/07/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/10/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 37 YR
• Patient Sex: Female