MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AORTO UNI-ILIAC [SUPRARENAL]

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Material Separation (1562); Torn Material (3024); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Rupture (2208)

Event Date 01/15/2017

Event Type  Death  

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.

Event Description

Patient initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2012.It was reported the patient expired on (b)(6) 2017.The physician identified a type 3b endoleak with a crown separation from the suprarenal aortic extension and a ruptured aortic aneurysm.The physician indicated the cause of the patient death is unknown, the physician was not able to determine if it was device related or other concurrent issues.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the following events; a type 3b endoleak with complete crown separation and a type 1a endoleak.Additionally there was evidence to support the following observations; near complete occlusion of the celiac trunk, near complete occlusion of the sma with dilated small bowel, placement of a right renal artery stent at an unknown date, complete occlusion of the right renal artery stent, and an atrophied non functional right kidney.The clinical evaluation identified the following contributing factors to the reported event; off label use due to patient anatomy, non-endologix stent in the right renal artery, occlusion of the renal stent, possible suboptimal placement of the proximal extension or migration of the device, occlusion of the sma, and occlusion of the celiac trunk.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices were not returned for further investigation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.

• Brand Name: AFX
• Type of Device: AORTO UNI-ILIAC [SUPRARENAL]
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6334832
• MDR Text Key: 67532990
• Report Number: 2031527-2017-00071
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1041753-017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2012
• 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: BIFURCATED- (B)(4)
• Patient Outcome(s): Death
• Patient Age: 73 YR