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

Model Number	FC-8-15-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil would not able to detach during the procedure.The patient underwent coiling treatment for small aneurysm, measuring 7.5mm x 11.5mm.It was reported that the physician deployed the coil into aneurysm, tried to detach multiple time with no success.It was reported that the physician attempted to detach the coil with two different instant detachers, but coil did not detach.The physician did not attempt with manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The physician then moved to another same size coil.The remaining coils deployed on first try.A total of 5 coils were deployed.A pipeline was deployed after the coiling of the large recurrent aneurysm.No patient injury was reported.The coil was prepared according to instruction for use (ifu).The vessel observed moderately tortuous.Yes, there was continuous flush administered during the procedure.
Additional Manufacturer Narrative
The axium prime pusher actuator interface was loose) from within the coupler tube.This indicates that there appears to have been an attempt to detach the implant utilizing the instant detacher.The axium prime pusher break indicator (bi) was found intact at the at the manual detachment location (via hypotube).No bends or kinks were found with the axium prime pusher.The axium prime coil was returned within its introducer sheath.The implant coil was found to be still attached to the pusher within the introducer sheath.The implant coil appears to be still in good condition.The axium prime coil was pushed out from within the introducer sheath without issue.Under the microscope, the coin was found to be located against the lumen stop, the shield coil was found to be present, and the implant coil was still attached to the pusher.As the actuator interface was not intact the axium prime coil could not be used with an in-house id.Therefore, the pusher was broken at the break indicator.Difficulty was encountered pulling the release wire out from within the pusher causing the release wire to break.This likely indicates that the coin is jammed at the lumen stop.Using tweezers, an accessible portion of the release wire was pulled causing the coin to pull out from the lumen stop, detaching the implant coil.Dried red residue (likely blood) was found on the coin.The coin was cleaned with alcohol to remove the dried residue.The coin appears to be in good condition.The coin width was measured @ 0.063mm to be 0.074mm, @ 0.127mm to be 0.092mm, and @ 0.275mm to be 0.095mm (specifications: @ 0.063mm: 0.063mm-0.089mm; @ 0.127mm: 0.075mm-0.105mm; @ 0.275mm: 0.086mm-0.108mm).Dried red residue (likely blood) was found on the lumen stop.The lumen stop was cleaned with alcohol to remove the dried residue.The lumen stop inner diameter was measured to be 0.0028¿ which is within specification (specification: 0.00220-0.0029¿).The shield coil was stretched and trimmed off to access the retainer ring.Dried red residue (likely blood) was found on the retainer ring.The retainer ring was cleaned with alcohol to remove the dried residue.The inner diameter of the retainer ring appears to be in good condition.The re tainer ring inner diameter was measured to be 0.0045¿ which is within specification (specification:.00455" ±.00010).No other anomalies were observed there was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿non-detachment¿ was confirmed.It is likely that the jammed condition of the coin in the lumen stop led to the difficulty during detachment both during the event as well as during testing; however, the cause for the coin ¿jamming¿ 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, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10208878
• Report Number: 2029214-2020-00622
• Device Sequence Number: 14261167
• Product Code: KRD
• UDI-Device Identifier: 00847536023055
• UDI-Public: 00847536023055
• Combination Product (Y/N): N
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 08/13/2021
• Device Model Number: FC-8-15-3D
• Device Catalogue Number: FC-8-15-3D
• Device Lot Number: A692382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1