MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A28-28/C95-O20

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

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.

Event Description

The patient had an initial procedure with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.A follow up computed tomography showed aneurysm sac growth, an endoleak was not reported.On (b)(6) 2017 the physician elected to implant an additional infrarenal aortic extension to seal the leak.The patient is reported to be in stable condition post repair procedure.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation confirmed a type 3b crown separation of the main body, migration and aneurysm sac growth.The clinical evaluation additionally found at implant there was a non-endologix stent placed in the left external iliac artery (leia) to treat stenosis.The clinical evaluation identified non compliance of follow up surveillance as a potential contributing factor to the reported event.The review of the manufacturing lot confirmed all devices met specifications prior to release.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 2.5%.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: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6387348
• MDR Text Key: 69360055
• Report Number: 2031527-2017-00100
• Device Sequence Number: 1
• Product Code: MIH
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: A28-28/C95-O20
• Device Lot Number: W11-4429-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2011
• 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: AORTO UNI-ILIAC [SUPRARENAL]- W11-4429-014
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR