MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Torn Material (3024)

Patient Problem Failure of Implant (1924)

Event Date 07/19/2013

Event Type  Injury  

Manufacturer Narrative

At the completion of the investigation, the clinical evaluation was able to confirm the type 3b endoleak with a tear in the main body, a type 1b endoleak following the placement of an additional bifurcated stent, the placement of a limb stent in the right iliac, a persistent type 2 endoleak in the right iliac, a non-endologix stent placement in the left iliac with a persistent type 1b endoleak remaining, and the resolution of the persistent type 1b and type 2 endoleaks.Additionally there was evidence to reasonably support the following observations; type 2 or a type 1b endoleak at 4 months post the initial procedure and the patient experienced hypoxia at the completion of the procedure.The clinical assessment was based on adequate medical records and adequate patient images.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The root cause of the reported event is unknown, there is not enough information to determine the root cause of the reported event.The event devices remain implanted in the patient and were not available for further evaluation.The clinical evaluation found further evidence to reasonably suggest the following contributing factors to the reported event; off label use, patient anatomy, and the covering of the right internal iliac artery without prior embolization.Devices remain implanted in the patient.

Event Description

Patient initially implanted with a bifurcated stent, a suprarenal aortic extension, and two infrarenal aortic extensions on (b)(6) 2012.During the initial procedure the placement of the proximal extension was suboptimal and the placement led to stenosis of the right renal artery.The physician elected to complete angioplasty and place one non-endologix stent in right renal artery lower pole and a non-endologix stent in the left renal artery lower pole.On (b)(6) 2013 a follow up angiogram showed the patient had a type 3b endoleak of the main body graft.On (b)(6) 2013 the patient underwent a subsequent endovascular procedure and a tear in the main body graft material as well as a potential type 1b endoleak was identified during the repair.The physician elected to implant an additional bifurcated stent and also implanted a limb extension into the right iliac limb and a non-endologix stent into the left iliac limb to seal the leak.Following the procedure there was a persistent leak.The patient returned on (b)(6) 2013 for repair of a type 1b endoleak and a type 2 endoleak.The physician completed a right hypogastric ligation and left common iliac artery banding to resolve the endoleaks.The patient was stable following the procedure.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6137394
• MDR Text Key: 61188616
• Report Number: 2031527-2016-00556
• 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
• Report Date: 07/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: BA28-90/I16-30
• Device Lot Number: W11-5881-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2011
• 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: INFRARENAL AORTO UNI-ILIAC- (B)(4); INFRARENAL AORTO UNI-ILIAC- (B)(4); LIMB STENT- (B)(4); LIMB STENT- (B)(4); LIMB STENT- (B)(4); NON-ENDOLOGIX RENAL STENT-LEFT; NON-ENDOLOGIX RENAL STENT-RIGHT; SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR