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

Model Number	QC-10-30-3D
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting gu idance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.H3: product analysis: as found condition: the axium coil was returned for analysis within shipping box; and within a sealed plastic bio-pouch.The micro catheter used during the event will not be returned for analysis.In addition, the model or lot number were not provided; therefore, compatibility could not be assessed.Visual inspection/damage location details: the axium implant coil was returned within the introducer sheath.The axium coil was found to be inverted within the introducer sheath with the wavelock at the distal end.The axium pushwire was found to be bent at ~26.8cm from proximal end.The axium implant coil appeared to be damaged and stretched within the introducer sheath.However, the returned coil was found to be helix coil not 3d coil.No other anomalies were observed.¿ testing/analysis: the implant coil was unable to be pushed out from the introducer.The axium coil could not be used for testing with an in-house microcatheter due to its damaged condition.The length of coil was measured to be ~15.0cm which is not 30cm.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ and " coil stretched" were confirmed.Advancing the axium coil against resistance would result in damage to the implant coil and pushiwre.Possible causes for coil resistance in catheter are, but not limited to, use of damaged/incompatible catheter, tortuous patient anatomy, repositioning and failure to hydrate the axium coil prior to use.For coil incorrect size see advancing the axium coil against resistance would result in damage to the implant coil and pushiwre.Possible causes for coil resistance in catheter are, but not limited to, use of damaged/incompatible catheter, tortuous patient anatomy, repositioning and failure to hydrate the axium coil prior to use.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the axium coil was stretched during the delivery in the microcatheter and could not be pushed out smoothly.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right c6 with a max diameter of 12.6mm and a 5.48mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the axium coil was stretched during delivery in the microcatheter and could not be pushed out smoothly.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.Additional information received reported there were no other other issues during that procedure that would have caused the damage.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21746183
• Report Number: 2029214-2025-00833
• Device Sequence Number: 13116343
• Product Code: KRD
• UDI-Device Identifier: 00847536030138
• UDI-Public: 00847536030138
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 07/25/2024
• Device Model Number: QC-10-30-3D
• Device Catalogue Number: QC-10-30-3D
• Device Lot Number: B240084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1261-2022
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male