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

Model Number BA25-80/I16-40

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that approximately 4 months post implant of a bifurcated device and a infrarenal aortic extension, the patient presented emergently to the hospital emergency room on (b)(6) 2014 and was symptomatic with abdominal pain.The hospital performed a computed tomography scan.At first the physician felt the pain was being caused by the patient's gall bladder; however, an endoleak was detected on the ct scan.It was reported to be coming from the distal bifurcated main body or just at or above the bifurcation.At the present time they are treating the gall bladder.The physician plans on scheduling the secondary intervention to reline the device with a new device in (b)(6) 2015.Note: the patient had a 30 day follow-up on (b)(6) 2014 and the physician indicated there was no endoleak present at the time.The physician feels the endoleak occurred sometime after the ct scan was performed on (b)(6) 2014 and was visualized on (b)(6) 2014.

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.Device remains implanted in patient.

Manufacturer Narrative

The device remains implanted in the patient and is therefore, not available for analysis.Medical records and imaging were provided and reviewed by an internal clinical representative with the following impression: no medical documentation and suboptimal imaging studies were available for this review.Product use might have been incongruent with the ifu due to the reported focal stenosis of the left common iliac artery.Cautionary product use conditions that might have contributed to this event included the aortic extension diameter was the same as the bifurcated diameter.At two months post implant, there was evidence to support a partial stent collapse, which created fabric billowing verses an endoleak approx.5 cm superior to the bifurcation.There was no sac increase and adequate stent overlap.Reportedly, four months post implant, the patient presented with abdominal pain due to gallbladder issues.The ct scan demonstrated a reduction in sac size, with an unchanged appearance of the partial stent collapse and fabric billowing verses endoleak seen two months prior.However, six months post implant, a bifurcated stent relining was confirmed.The still photos demonstrated an angiogram post a stent relining.The blue arrows were added to indicate where the sales representative reported the endoleak, which was near a right distal strut.This event was reviewed by the complaint review team on (b)(6) 2015 and due to lack of sufficient radiological evidence, this case will be coded as an unknown endoleak.A manufacturing record review was performed, the lot met all release criteria with no issues or deviations that would explain the reported event.The lot usage history showed no other units from this lot were involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.Based upon the investigation findings, the root cause could not be conclusively determined with available information.

• Brand Name: AFX SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: gail hapner ; 2 musick; irvine, CA 92618 ; 9495984611
• MDR Report Key: 4372410
• MDR Text Key: 16177343
• Report Number: 2031527-2014-00422
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1055356-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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
• Patient Age: 61 YR