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

Model Number	QC-2-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil was stuck in the sheath and could not be pushed into the microcatheter after preparation.The device was replaced, and the event was said to be not associated with the patient. the devices were prepared according to the instructions for use (ifu).Ancillary devices include an echelon 10 microcatheter.Additional information was received.The coil was prepped per ifu, but the account was not sure it was held vertical.
Additional Manufacturer Narrative
As found condition: the axium coil was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.Visual inspection/damage location details: the axium implant coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium pushwire was found to be broken at ~6.8cm from proximal end and retained by release wire.The axium implant coil was found to be damaged within the introducer sheath.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: the axium coil was not able to be pushed out from within the introducer sheath due to resistance.The axium implant coil tip od (outer diameter) was found to be 0.0113¿ which is within specifications.The id (inner diameter) of the introducer sheath was found to be 0.0185" (0.4699mm) which is within specifications.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issue pushing the axium coil out from within the introducer sheath for hydration.Therefore, it is likely that the implant coil became damaged during return of the implant coil back into the introducer sheath or due to an improper hubbing technique (over tightening of the rhv).Regarding the damage to the pushwire, as the issue was not reported by the customer it is likely the damage occurred during return to medtronic for evaluation.There was no non-conformance to specifications identified that led to the reported issue.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: 13876558
• Report Number: 2029214-2022-00467
• Device Sequence Number: 4520158
• Product Code: KRD
• UDI-Device Identifier: 00847536029828
• UDI-Public: 00847536029828
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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: 01/05/2024
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: B140720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Date Device Manufactured: 01/05/2021
• 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 Sex: Unknown