MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I16-40

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Occlusion (1984)

Event Date 12/04/2017

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 was initially implanted with a bifurcated stent, a suprarenal aortic extension and 3 limb stents.During the initial procedure the physician elected to place two bilateral iliac hypogastric snorkels due to the iliac aneurysms present.A follow up computed tomography angiogram (cta) showed the patient had a type 3a endoleak with component separation between the an iliac limb stent and main body device.The cta also showed the patient had an occlusion of the left iliac hypogastric snorkel and a possible type 3b endoleak.A secondary procedure was completed on (b)(6) 2017 where the physician placed two additional limb extensions to seal the leak.The physician reported there was no type 3b endoleak observed during the secondary procedure.The patient is reported to be doing well post procedure.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.It was confirmed that patient had a endoleak type 3a-complete separation of left iliac limb extension and main body; a left internal iliac artery stent occlusion (from a non-elgx device); and a secondary endovascular procedure of 2 iliac limb extensions to bridge the 3a endoleak.In addition, on (b)(6) 2013 (1 month post implant), patient had an occlusion of the liia snorkel, resulting in claudication of the left buttock and thigh.On (b)(6) 2013 (2 month post implant), physician attempted cannulation of the occluded the liia stent.At 53 month post implant on (b)(6) 2017, patient had an aneurysm enlargement of the lcia that was noted.During a follow up cta on (b)(6) 2018, a endologix rep informed us that a type 3b endoleak was noted on the main body.On (b)(6) 2018, a 3b repair/re-line was performed to correct issue.No further information was provided on patient current condition.This was patient's 3rd procedure.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the loss of seal was related to the off-label procedure with placement of bilateral internal iliac artery snorkels.The cautionary product use of non-compliance to follow-up imaging surveillance likely contributed to the event.Additionally, the non-endologix left internal iliac artery snorkel stent was occluded and noted at the one month follow-up.At 2 months post implant an unsuccessful attempt was made to treat the occlusion.The most likely cause of the occlusion of the non-endologix stent was impingement between the iliac limb extension at the iliac bifurcation.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7154666
• MDR Text Key: 96048502
• Report Number: 2031527-2017-00705
• 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: 12/04/2017

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: 10/31/2015
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1046821-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIMB STENT GRAFT- (B)(4); LIMB STENT GRAFT- (B)(4); LIMB STENT GRAFT- (B)(4); SUPRARENAL AORTIC EXTENSION- (B)(4); LIMB STENT GRAFT- (B)(4); LIMB STENT GRAFT- (B)(4); LIMB STENT GRAFT- (B)(4); SUPRARENAL AORTIC EXTENSION- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR