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

Model Number BA28-90/I16-30

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888); Therapeutic Response, Decreased (2271); Test Result (2695)

Event Date 12/15/2014

Event Type  Injury  

Event Description

It was reported that approximately 25 months post implant of a bifurcated device and a suprarenal aortic extension, there was an endoleak.Reportedly, the patient came in for a follow up and a computed tomography scan was performed and displayed the aneurysm growing.However, there was also a hole in the fork of the bifurcated device.The physician has planned to treat the patient on (b)(6) 2014, reline with a bifurcated device, and a cuff.Additional information- it was reported the patient came in on (b)(6) 2014 for a secondary procedure.The physician treated the endoleak, and the patient is doing well.

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.

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: suboptimal medical documentation and imaging studies were available for this review.Product use was congruent with the ifu.Cautionary product use conditions that might have contributed to this complaint included the tortuous, calcified bilateral iliac arteries.Twenty-six months post implant there was evidence to the secondary procedure, however that angiogram did not include pre intervention imaging to confirm the reported type iiib endoleak.The final patient disposition could not be established due to lack of information.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 all units have been consumed and 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 determined based upon 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: 4372390
• MDR Text Key: 17222766
• Report Number: 2031527-2014-00415
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1045628-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• 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: 08/28/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR