MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BEA28-120/I20-40

Device Problems Collapse (1099); Hole In Material (1293); Kinked (1339); Leak/Splash (1354); Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains 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

It was reported the patient had an initial procedure with a bifurcated device.On (b)(6) 2017 a follow up computed tomography (ct) showed unintended movement laterally of the device and a kink in the proximal portion of the device.The physician is planning to reline the initial implant.To date there are no reports of the patient having completed the secondary procedure nor scheduled for a secondary procedure.The current patient status is unknown and was not initially reported to endologix.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a stent migration, and a total stent collapse that was non-flow limiting.There was also enough evidence to support the following observations; a type 2 endoleak and a type 3b endoleak near the total stent collapse.The clinical evaluation additionally found the following potential contributing factors to the reported event; off label use due to patient anatomy, patent lumbar arteries, patent inferior mesenteric artery, a total stent collapse, and calcification in the left aortic wall.The review of the manufacturing lot confirmed all devices met specifications prior to release.The root cause of the stent collapse and type 2 endoleak is unknown.There is not enough information to determine the cause of the collapsed stent and type 2 endoleak.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; 1.Upgraded graft material (i.E.Duraply) and 2.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 2.5%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to <0.2%.Correction: device codes have been updated.

Event Description

Additional information received, the patient had a secondary procedure completed on (b)(6) 2017.The physician implanted a suprarenal aortic extension and an infrarenal aortic extension to seal the endoleak.The patient is reported to be in stable condition following the procedure.

• 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
• MDR Report Key: 6446508
• MDR Text Key: 71274373
• Report Number: 2031527-2017-00129
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)170427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO40002
• 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: 03/01/2017

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: 04/27/2017
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 1354739-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR