MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA25-110/I16-30

Device Problems Break (1069); Collapse (1099); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.To date no device received.

Event Description

It was reported the physician had difficulty deploying the bifurcated stent during the initial implant of the device.The physician stated there was resistance while pulling the control cord and eventually the control cord broke.A portion of the proximal stent graft remained closed following the damage to the cord.In withdrawing the tip of the delivery system the physician pulled strongly and the proximal section of the stent opened.The force of the withdraw left the proximal end crushed.The physician implanted a non-endologix gore device to resolve the issue.The patient is reported to be in good condition following the procedure.

Manufacturer Narrative

(b)(4).In addition to the difficulty in deploying, clinical assessment identified an unknown endoleak near the distal region of the bifurcated stent graft.The root cause of the reported difficulty deploying the bifurcated stent is unknown.The root cause of the endoleak of unknown origin was likely due to user-procedure related error.Clinical assessment identified that there was off label use of concomitant products, which is outside the ifu.Additionally, significant manipulations of the bifurcated stent graft delivery system following control cord break likely contributed to the event.Clinical was able to confirm the reported difficult deployment of the main body, collapsed proximal section of the main body, 2 non-endologix proximal extensions, and an unknown endoleak near distal bifurcated stent graft.Additionally, there was evidence to reasonably support the following observations: 2 non-endologix self-expanding stents placed in right iliac limb and right common iliac artery, and 1 non-endologix self-expanding stent placed in left iliac limb.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.The devices were not returned, therefore no physical evaluation was completed.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6505466
• MDR Text Key: 73232287
• Report Number: 2031527-2017-00175
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012395
• UDI-Public: (01)00818009012395(17)180126
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PO40002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1252353-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: 03/20/2017
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1