MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A28-28/C95-O20

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Separation (1562); Stretched (1601); Use of Device Problem (1670)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Ischemia (1942); Renal Failure (2041); Rupture (2208); Respiratory Failure (2484)

Event Date 06/07/2018

Event Type  Death  

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.

Event Description

The patient was initially implanted with an afx to treat an abdominal aortic aneurysm.3 years after the original implant a secondary procedure was performed to address a type lllb endoleak.Two years post-secondary procedure a tertiary procedure was performed to address a type la endoleak of the cuff.The physician elected to repair the leak by covering the left renal cuff.The physician stated that he did not identify any loss of integrity in the main body.On (b)(6) 2018, five days post tertiary procedure, the patient expired.The cause of death is unknown at this time.

Manufacturer Narrative

Clinical evaluations was able to find substantial evidence to support the following reported events; type ia endoleak (cuff) and death.Clinical was able to find additional evidence that was not reported with the initial reported event.Clinical assessment determined that there was evidence to reasonable suggest stent cage dilation of the cuff (20%) and main body (78%), rupture, sac growth of 24.5 mm and crown separation.These events were discovered during review of the 43 month post implant ct scan.The patient death was determined to be device related.The manufacturing records confirm that the lots met all requirements prior to release.Device remains implanted in the patient and was not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: concomitant medical products and therapy dates - remove 1050592-057.

Event Description

Additional information received per clinical assessment confirming that the patient had an off-label neck anatomy at the time of the initial implant.In addition, the following observations were confirmed present at the time of the reported event: acute renal failure, lower leg ischemia, acute respiratory failure, rupture, aneurysm sac growth by 24.5mm, crown separation, and stent cage dilation of the proximal extension (20%) and bifurcated device (78%).

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7648862
• MDR Text Key: 112692357
• Report Number: 2031527-2018-00574
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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: 06/30/2016
• Device Model Number: A28-28/C95-O20
• Device Catalogue Number: F00553
• Device Lot Number: 1050592-057
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT, LOT 1053281-014; LIMB STENT GRAFT, LOT 1039909-017; SUPRARENAL AORTIC EXTENSION, LOT 1050592-057
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR