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

Model Number	FC-4-12-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 a report that the coil would not detach.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left posterior communicating artery.The max diameter was 4.5mm, and the neck diameter was 4.2mm.The patient's blood flow and vessel tortuosity were normal.It was reported that the physician tried several times to separate the coil using instant detacher (id), but it didn't detach.They physician tried to passively separate it by the manual way, but it was also impossible.The physician had tried to detach the coil more than 5 times with the id, and there was said to be no problems with the id. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
Event or Problem Description
Additional information received reported there was no issue with the instant detacher which was used successfully without issue with another coil.No other issues occurred prior to the coil non-detachment.No damage to the coil pushwire was noted.
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 axium prime was returned.The actuator interface was found loose on the coupler tube, indicative that a detachment was attempted at this location with an instant detacher.The break indicator was found intact.No evidence of manual detachment attempts was found at this location.The axium prime pusher was found kinked at 157.5cm from the proximal end.The coin was found still against the lumen stop.Blood was found under the jacket 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 retracted, and the coin did not exit the lumen stop.The break indicator was broken, and the release wire was retracted.However, the release wire was found stuck.Under magnification, the outer jacket was removed, and the blood was dissolved.The release wire was retracted, and the coin exited the lumen stop with no issues and no resistance encountered.No other damages or anomalies were found with the returned device.Based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachment is the blood found within the lumen stop and under the jacket caused the coin to become stuck within the lumen stop.The pusher was found kinked, and the implant coil was found damaged.Possible causes include, but not limited to, lack of hydration before procedure, continuous flush not performed during procedure (or insufficient continuous flush), tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances/retracts the coil against resistance or incompatible catheter.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment 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 FRAMING COIL
• 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: 11772934
• Report Number: 2029214-2021-00534
• Device Sequence Number: 14514375
• Product Code: KRD
• UDI-Device Identifier: 00847536022911
• UDI-Public: 00847536022911
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2021

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: 05/20/2021
• Device Model Number: FC-4-12-3D
• Device Catalogue Number: FC-4-12-3D
• Device Lot Number: A648929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 08/13/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1