MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-14-40-3D
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that axium coil could not be detached and there was resistance during detachment.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the clinoid segment.The max diameter was 15mm, and the neck diameter was 10mm.The patient's blood flow and vessel tortuosity were normal.It was reported that 3 attempts were made to detach the coil with the instant detached, 1 attempt was made with a second instant detacher, and 1 attempt was made manually.There were no issues with the instant detacher. the coil was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include an echelon 10 microcatheter.
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.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 axium coil was returned for analysis within a shipping box and within a plastic bio-pouch.¿ visual inspection/damage location details: the axium pusher was found bent and broke at ~179.5cm from pusher distal end.When compared to the drawing specification ~8.5cm of the axium pusher proximal end was found broken and not returned.The pusher was found bent at ~44.0cm from the pusher proximal end.The release wire coin was found against the lumen stop, the shield coil was intact, and the implant coil was found still attached to the pusher.The axium implant coil was found still in good condition.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in catheter¿ report could not be confirmed.Possible causes of ¿coil resistance/stuck in catheter¿ include use of an incompatible catheter, lack of hydration before procedure, user does not maintain a continuous flush, tortuous anatomy, or damage or kink to pusher.The echelon-10 micro catheter is compatible for use with the axium coil, the axium coil was prepared according to the instructions for use (ifu) which includes hydration, and the patient¿s vessel tortuosity was ¿normal¿.Therefore, use of an incompatible catheter, lack of hydration before procedure, and tortuous anatomy were ruled out as potential causes.Information regarding if a continuous flush was used was not reported.Therefore, user does not maintain a continuous flush could not be ruled out as a potential cause.It is possible the bent axium pusher contributed to the reported resistance.However, the cause for the resistance could not be determined.Regarding the customer¿s ¿non-detachment¿ report the issue was confirmed.The instant detachers (id) used in the event were not returned.Therefore, an analysis could not be performed, and any contributing factors could not be assessed.It is possible the manual detachment at the incorrect location contributed to the event.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: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 was received that resistance occurred in the distal section of the catheter.The coil came out of the introducer sheath smoothly.There was no kink/damage observed to the coil or catheter.

• Brand Name: AXIUM 3D
• 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: 15659165
• Report Number: 2029214-2022-01783
• Device Sequence Number: 5881975
• Product Code: KRD
• UDI-Device Identifier: 00847536037984
• UDI-Public: 00847536037984
• 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,Followup
• Report Date (Section B): 12/21/2022

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: 10/07/2024
• Device Model Number: QC-14-40-3D
• Device Catalogue Number: QC-14-40-3D
• Device Lot Number: 223086069
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 12/06/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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 Age: 58 YR
• Patient Sex: Male