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

Model Number	QC-6-20-3D
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) hospital.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.
Event or Problem Description
Medtronic received a report that two axium coils were stretched and there was coil separation/break/premature detachment.The pushwire was not bent or broken, and there had been no friction/difficulty during delivery.The physician had rotated the delivery wire during the procedure.A continuous flush had been administered, and the patient's blood flow and vessel tortuosity were normal. the patient did not experience any injury, symptoms, or additional medical/surgical intervention.The devices were prepared according to the instructions for use (ifu).
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 was received that the spring coil was partially broke and stretched.The coil did not prematurely separate from the delivery wire.Part of the coil was separated from the rest.There were no other issues.There were no issues that resulted in the damage that was found.The entire coil was removed from the patient.
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: two axium coils were returned for analysis within a shipping box; within individual sealed biohazard pouches; within dispenser coils and within introducer sheaths.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: (pli-10) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium pusher.No damages or irregularities were found with the shield coil.The axium implant coil was found still attached to the pusher and found stretched within the introducer sheath with the polypropylene filament broken.The implant coil was found unbroken.(pli-20) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium pusher.No damages or irregularities were found with the shield coil.The axium implant coil was found still attached to the pusher and found stretched within the introducer sheath with the polypropylene filament broken.The implant coil was found unbroken.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed for both devices.Possible causes of coil stretching are, lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance or incompatible catheter.Customer reported no friction/difficulty during delivery, continuous flush was administered, vessel tortuosity as normal, devices were prepared per ifu, and delivery wire was rotated during procedure.It is possible the rotation contributed towards the stretching.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil stretching could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The customer report of ¿coil separation/break¿ was not confirmed for both devices.Ngod10 2023-03-17 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): 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: 15597918
• Report Number: 2029214-2022-01708
• Device Sequence Number: 2265766
• Product Code: KRD
• UDI-Device Identifier: 00847536030039
• UDI-Public: 00847536030039
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2023

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: 07/13/2024
• Device Model Number: QC-6-20-3D
• Device Catalogue Number: QC-6-20-3D
• Device Lot Number: B234234
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 03/18/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/09/2022; 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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: 55 YR
• Patient Sex: Female