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

Model Number	QC-9-30-3D
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter (physician) information is not provided from (b)(4) due to privacy laws.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 had premature detachment after failing to detach during detachment attempts and the coil was stretched.It was reported that the device was prepared according to the instructions for use (ifu).After the coil was delivered, an attempt was made to detach it with instant detacher (id) but it would not detach and it was noted that the coil "stump" was stretched when detachment was attempted to be forced.3 attempts were made to detach the coil with id without success.The physician also attempted 4-5 times to detach manually, but this also failed.Finally, it was tried to retrieve the coil and then the core wire detached and could not be pulled.The coil was able to be recaptured and retrieved and was replaced with another product.No patient information was reported.
Event or Problem Description
Additional information received reported confirmation that there was no effect on the patient related to the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: the proximal pusher (actuator interface, positive load indicator, break indicator, coupler tube) was separated from the rest of the pusher and not returned.The release wire was found extending out of the proximal end of the returned segment.The release wire was found kinked within the distal pusher under the shrink tubing.The coin was found still within the lumen stop.Blood was found under the shrink tubing and within the lumen stop.The implant coil was found still attached to the pusher.The implant coil was found to be damaged.The exposed release wire was pulled back, however, was found to be stuck within the pusher.Under magnification, the outer jacket was removed distal to the kinked release wire, and the blood was dissolved.The release wire was then retracted, and the coin retracted out of the lumen stop, detaching the implant coil with no issues or resistance.Based on the customer report and device analysis, the customer report of "premature detach.From a non-detach" was not confirmed as the returned axium implant coil was still attached to the pusher.Non-detachment was confirmed, however.It is likely the kink found on the release wire and the dried blood caused the reported non-detachment as the resistance of the release wire was not found after the blood was dissolved and the release wire distal to the kink was retracted.The pusher was found broken distal to the break indicator, indicative of manual detachment attempts.The implant coil was found damaged.The instant detacher, actuator interface, positive load indicator, break indicator, and coupler tube used in the event was not returned.Therefore, any contribution of these subassemblies and the instant detacher towards the premature detach from non-detachment and conformance to specification could not be assessed.There is no indication that the event is related to a potential manufacturing issue, therefore a device history record review was not required.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
• MDR Report Key: 11820559
• Report Number: 2029214-2021-00571
• Device Sequence Number: 19770141
• Product Code: KRD
• UDI-Device Identifier: 00836462010451
• UDI-Public: 00836462010451
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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: 01/07/2022
• Device Model Number: QC-9-30-3D
• Device Catalogue Number: QC-9-30-3D
• Device Lot Number: A763356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 07/29/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/07/2021; 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1