MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiopulmonary Arrest (1765); Failure of Implant (1924); Occlusion (1984); Perforation of Vessels (2135); Stenosis (2263); Blood Loss (2597)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.

Event Description

Patient initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2013.A follow up with the patient identified a type 3a and a type 3b endoleak with component separation.The physician elected to reline the initial devices on (b)(6) 2016 by implanting three additional infrarenal aortic extensions to seal the endoleak.The patient is in stable condition post procedure.

Manufacturer Narrative

At the completion of the investigation based on the information available, clinical was able to confirm the following type iiib endoleak of the cuff.However, the reported type iiia endoleak most likely was reflective of the complete crown separation of the cuff, which is reflective of a type ia endoleak of the cuff.Notably the aortic neck diameter was greater than 32mm (off-label repair procedure).Additionally there was evidence to reasonably support the following observations; urgent readmission for a right common femoral artery perforation and blood loss, complete crown separation of the suprarenal cuff, strut cage dilation, complete stent collapse of the main body, unusual strut pattern of the left common iliac portion, observed femoral-femoral artery bypass, urgent presentation on day of release, successful cardio pulmonary resuscitation; perforated right femoral artery with retroperitoneal bleed with a placement of a non-endologix stent; off-label repair due to the growth of the juxtarenal aneurysm beyond 39mm.The manufacturing lot evaluation confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Based on the information available the root cause of the reported event is unknown.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; off-label neck anatomy, off-label cuff size, unusual stent cage presentation of the left common iliac portion of the main body stent, and the shorter than expected appearance of that stent and small calcified bifurcation, off-label right iliac diameter, and sudden acute presentation of groin pain immediately post a strained effort to get up indicates an acute event of the right access vessel (closure device, suture, or thrombic plug failure).A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4)%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to <0.2%.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6123592
• MDR Text Key: 60744036
• Report Number: 2031527-2016-00550
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

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: 09/30/2015
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1047100-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: 10/28/2016
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2012
• 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
• Treatment: SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR