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 Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium pusher was returned for analysis.The axium pusher was found bent at ~1.0cm from the proximal end.The pusher was found broken at the positive load indicator and at the break indicator.The release wire was fully retracted out of the pusher.The coin was retracted out of the lumen stop.The shield coil was found intact, and the implant coil was already detached and not returned for analysis.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink/damage¿ was confirmed.The pusher was found broken, with the release wire/coin retracted out of the lumen stop, detaching the implant coil as designed by the detachment elements.Customer report of device damaged out of packaging could not be confirmed.The device appears to be further damaged beyond the reported bend found during opening of the packaging.As the dispenser coil and black guidewire clip was not returned, any contribution of the dispenser coil and black guidewire clip to the failure could not be determined.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, it is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.Therefore, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil was bent out of the package.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the left internal communicating artery with a max diameter of 4mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the coil came out of package with the wire bent.The damage was on the pushwire proximal segment.Physician wasn¿t comfortable using in patient.The coil was never placed in a catheter or the patient.The reported device and any accessory devices prepared as indicated in the ifu.Additional information received reported that there was no damage or evidence of tampering to the device packaging.The damage to the device was noted upon opening the package, and no preparation had been performed.The proximal end of the pushwire had been secured in the guidewire clip when the package was opened.
Additional Manufacturer Narrative
Imf code f26 updated to f27.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: 12957619
• Report Number: 2029214-2021-01577
• Device Sequence Number: 1728840
• Product Code: KRD
• UDI-Device Identifier: 00847536029828
• UDI-Public: 00847536029828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/08/2021

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: 05/10/2024
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: B204343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 73 KG