MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Device Problems Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Failure of Implant (1924); Pain (1994); Pain (1994); Misdiagnosis (2159); Rupture (2208); Rupture (2208)

Event Type  Injury  

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 on (b)(6) 2012.On (b)(6) 2015 the patient came in emergently with a rupture and found to have a type 1a endoleak.The physician elected to implant a suprarenal aortic extension to seal the endoleak.In (b)(6) 2015, the patient presented with flank pain and was referred to another hospital.Patient did not follow up with the referral and presented with an emergent rupture on (b)(6) 2016.The physician elected to explant the devices and complete an open repair.The patient is in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information available, the clinical evaluation was able to confirm a type 3 endoleak with component separation.There was also evidence to support the following observations; non-treatment of component separation at 19 months post initial procedure, total stent collapse at 32 months post procedure, non-treatment of a hematoma and sac growth.The clinical evaluation additionally found the following potential contributing factors to the reported event; a newly formed juxtarenal abdominal aortic aneurysm, off label use of the proximal extension, untreated/unrecognized contained rupture five months prior to rupture, horizontal movement and remodeling of the main body stent.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices were not returned, further evaluation could not be completed.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: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6460505
• MDR Text Key: 143063456
• Report Number: 2031527-2016-00245
• 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
• Type of Report: Initial,Followup
• Report Date: 03/10/2017
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: 03/10/2017
• Supplement Dates FDA Received: 04/05/2017
• Type of Device Usage: N
• Patient Sequence Number: 0