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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an axium coil that detached prematurely.The patient was undergoing a coil embolization procedure to treat a ruptured saccular right posterior communicating artery aneurysm.The aneurysm max diameter was 5.9mm and the neck diameter was 4mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The axium coil (model: qc-6-20-3d, lot: b115267) was selected to form the hoop.The coil was adjusted twice during the process of forming the hoop and during an adjustment it was observed that the coil had detached from the pusher.There was no friction or other difficulty during the delivery process.The physician did not rotate the pusher during the procedure and there was no damage noted to the pusher.There was no attempt made to detach the coil.Continuous flush was administered during the procedure.The coil detached in the microcatheter so the devices were removed together and the coil was replaced with another of the same model and the operation proceeded without issue.There was no harm or injury to the patient.Ancillary device: echelon 10 microcatheter.
Additional Manufacturer Narrative
H3: the axium coil returned for analysis within a shipping box; and within a sealed plastic bio-pouch; within an opened axium inner pouch and a dispenser coil.There was no implant coil, microcatheter or instant detacher returned with the device.Visual inspection/damage location details: the axium pusher was returned within its introducer sheath.The axium coil was found to be inverted within the introducer sheath with the wavelock at the distal end.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.There is no evidence of any detachment attempts by mechanical or manual methods.The axium pushwire was found to be bent within introducer sheath from ~8.4cm to ~6.5cm from distal end.The implant coil was already detached and not returned for analysis.The intact coin was found pulled back and away from lumen stop and was not in skive area.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.083mm @ 0.063mm; measured 0.089mm @ 0.127mm; measured 0.090mm @ 0.275mm.The lumen stop inner diameter (id) was measured to be 0.00287¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00459¿and found to be within specification.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be damaged (ovalized).Conclusion: based on the analysis performed, the customer report of ¿premature detachment¿ could not be confirmed.The pusher was returned with the implant coil already detached which is indicative of premature detachment, however, it is not possible to confirm that the implant coil could not detach prior to this.There is no evidence of any detachment attempts by mechanical or manual methods.The pusher was found bent, indicative of high patient tortuosity, advancing/retracting device against resistance.The retainer ring and lumen stop were found damaged (ovalized).It is possible the damage to the retainer ring contributed towards the premature detachment.It is likely the damage occurred during the customer reported manipulation that caused the coil to eventually detached.Since the implant coil, detached element, instant detacher and microcatheter were not returned, any contribution of the implant coil, detached element, instant detacher or microcatheter to the issue could not be determined.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: 13237151
• Report Number: 2029214-2022-00043
• Device Sequence Number: 4307533
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 11/09/2023
• Device Model Number: QC-6-20-3D
• Device Catalogue Number: QC-6-20-3D
• Device Lot Number: B115267
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 03/12/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/28/2022
• Date Device Manufactured: 11/09/2020
• 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: 52 YR
• Patient Sex: Female