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

Model Number APB-3-4-3D-ES

Device Problems Use of Device Problem (1670); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an axium coil that had a detachment issue and the release wire broke.The patient was being treated for a ruptured saccular aneurysm of the anterior communicating artery (acom) with subarachnoid hemorrhage.The aneurysm max diameter was 3mm and the neck diameter was 2mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that all devices were prepared per the instructions for use (ifu).The coil was delivered through the microcatheter with no resistance felt during delivery.The coil was implanted as intended in the aneurysm.An attempt was made to detach the coil with the instant detacher (id) but was not successful though the id was new.An attempt was then made to detach the coil by manual method.However, when the break indicator was broken and the manual detachment method was performed, the release wire that should appear from the break indicator part was torn, and the release wire was physically broken.The entire system was removed from the patient's body.The coil was replaced with a non-medtronic product and the procedure was then completed successfully.There was no harm or injury to the patient.

Manufacturer Narrative

H3: the pushwire was returned within introducer sheath.Upon visual inspection, the proximal end of pushwire was found to be broken at break indicator but retained by release wire.There appeared to be evidence of detachment attempts by mechanical or manual methods.The coin was found to be present but not against the lumen stop.The implant coil was returned already detached.Under the microscope, the outer jacket was then removed to gain access to the coin.The coin appeared to be damaged.The coin was measured in 3 locations and found to be within specifications.At 0.063mm the coin was measured to be ~0.082mm, at ~0.127mm it was measured to be ~0.085mm and at ~0.275mm it was measured to be ~0.094mm.The lumen stop was found to be visually acceptable.The lumen stop inner dia meter (id) was measured to be 0.00290¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The retainer ring was found to be damaged (ovalized) and unable to be measured.Implant coil was found to be stretched and dama ged.No other anomalies were observed.Based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium prime was returned with the implant already detached.It is likely that the premature detachment is due to the damage to the retainer ring, however, the cause could not be determined.It is possible that the retainer ring was damaged if the coil was not retracted in a one-to-one motion with the implant pusher during repositioning.Possible causes for premature detachment are tortuous anatomy, pusher rotation and the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.The review of lot 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.

• Brand Name: AXIUM PRIME BRPL 3D
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10928264
• MDR Text Key: 219523037
• Report Number: 2029214-2020-01212
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (y/n): N
• PMA/PMN Number: K151447
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: A994436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1