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

Model Number FC-4-12-3D

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

It was reported the physician information could not be provided due to restriction by privacy regulations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the coil was detached prematurely, and an attempt was made to retrieve the coil but it flowed distally and remained in the patient.When an attempt was made to retrieve the coil with a snare, it was unsuccessful and hemorrhage occurred.Eventually, the anterior cerebral artery was infarcted/clogged.It was noted there was no damage to the pushwire, no resistance during delivery, no repositioning or rotation performed, no detachment attempts were made, and a continuous flush was used.It was indicated that all devices were prepared as per the instructions for use (ifu), and the patient was in bad condition.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the anterior communicating artery with a max diameter of 4 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.

Manufacturer Narrative

B5.Updated with additional information received from the health care provider via the manufacturer representative.H6.Coding updated related to analysis results.Product analysis results: the axium prime pusher (model: fc-4-12-3d lot: a886408) was returned for analysis within a shipping box, within a resealable plastic pouch, within an opened axium prime outer carton and within a second resealable plastic pouch.The axium prime inner pouch label was also returned.The axium prime pusher was decontaminated.The actuator interface was securely attached to the coupler tube and the break indicator was found intact.There was no evidence of detachment attempts at these locations.The axium prime pusher was found kinked at ~3.5cm and at ~2.4cm from the distal end.The coin was found still up against the lumen stop and the shield coil was found intact.The shield coil was removed, and the release wire was still extending out of the retainer ring ~0.003¿.The retainer ring was found damaged (ovalized).The inner diameter of the retainer ring was measured to be 0.00530¿ at the long diameter and ~0.00440¿ at the small diameter which is no longer within specification (0.00455" +/- 0.00010").Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.083mm @ 0.063mm; measured 0.093mm @ 0.127mm; measured 0.098mm @ 0.275mm.The inner diameter of the lumen stop was found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.0028¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The implant coil was already detached and not returned for analysis.Customer reported the coil remained within the patient.No other anomalies were observed.Based on the analysis performed the axium prime coil was confirmed to have prematurely detached as the implant coil was detached from the pusher.There was no evidence of detachment attempts, the coin was still against the lumen stop and the release wire was still within the retainer ring.The likely cause of the premature detachment was the damage found on the retainer ring, causing the inner diameter to exceed specification; leading to the detach element to slip out of the retainer ring and detaching the implant coil.The cause of the damage to retainer ring could not be determined from analysis of device.Possible causes for damage to retainer ring include but not limited to tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation or user advances/retracts the device against resistance.Customer reported no damage to pushwire, no resistance during delivery, no detachment was attempted, no repositioning or rotation performed, continuous flush was used, and device were prepared per ifu.The distal pusher was found kinked, indicative of advancing the device against resistance.As the axium prime pusher was returned without its protective dispenser coil and introducer sheath, the damage could have also occurred during handling or return shipping to medtronic for analysis.As the implant coil was not returned for analysis, any contribution of the implant coil towards the premature detachment could not be determined.The review of device history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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 Description

Additional information received reported that the detached coil was implanted at the anterior cerebral artery (aca).A stent was placed to hold the coil in place and prevent the coil from moving further distal.After the the infarct of the patient's aca, the patient's condition was noted to be poor.However, at time of follow-up, the patient was trending toward recovery under monitoring.There was no plan for additional medical or surgical intervention at time of follow-up.No images were available.

• Brand Name: AXIUM FRAMING COIL
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10848453
• MDR Text Key: 216946904
• Report Number: 2029214-2020-01134
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K162704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: FC-4-12-3D
• Device Catalogue Number: FC-4-12-3D
• Device Lot Number: A886408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention