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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pushwire was returned for evaluation within the introducer sheath; inside of a biohazard bag and a shipping box.There was no implant coil returned with the pushwire.¿ visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil was intact with no damage.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); it appeared that the manual detachment was attempted at this location.The ai and coupler tubing were present and intact; it appeared that the mechanical detachment was not attempted at this location.Bends were found at 24.0cm to 37.0cm from the proximal end.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ testing/analysis: the pushwire was removed from the sheath with difficulty.The ¿wave lock¿ portion of the introducer sheath was present near the proximal end.The introducer sheath id (inner diameter) was measured to be 0.0190" (0.44mm) found to be within specifications.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.086mm @ 0.127mm; measured 0.094mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00270¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00460¿ and found to be within specification.¿ conclusion: based on the analysis performed, the customer complaint was confirmed as the pushwire was returned stuck inside the introducer sheath.In addition, the pushwire was found damaged.However, the root cause and the cause for damages could not be determined.The customer did not report any issues pushing the implant coil out from the introducer sheath during the hydration process.Therefore, it is possible that damages occurred during preparation or due to an improper hubbing technique (over tightening of the rhv).In additionally, the pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.There was no non-conformance to specification identified that that led to the reported issue.Since the implant coil was not returned; any contribution of the implant coil to the issues 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.
Event or Problem Description
Medtronic received a report that the axium coil was not able to enter the catheter due to severe resistance in the sheath. the coil was replaced, and the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right posterior communicating artery.The max diameter was 15mm, and the neck diameter was 8mm.The patient's vessel tortuosity was normal, and their vessel tortuosity was moderate.Ancillary devices include an envoy 6f guide catheter and headway 17 microcatheter.Additional information received reported that during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• 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: 15202108
• Report Number: 2029214-2022-01327
• Device Sequence Number: 6413210
• Product Code: KRD
• UDI-Device Identifier: 00847536030176
• UDI-Public: 00847536030176
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 12/02/2023
• Device Model Number: QC-14-40-3D
• Device Catalogue Number: QC-14-40-3D
• Device Lot Number: B125791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/10/2022
• Date Device Manufactured: 12/02/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown