MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM; SUPRARENAL PROXIMAL EXTENSION STENT GRAFT

Model Number A25-25/C95-O20

Device Problems Leak/Splash (1354); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2014

Event Type  Injury  

Event Description

It was reported that approximately 37 months post implant of a bifurcated device and a suprarenal aortic extension an endoleak was identified.The patient had a ct and physician elected to reline the overlap with 2 cuffs.Patient is doing fine.

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: product use was incongruent with the ifu due to: the greater than 60 aortic neck.Cautionary product use conditions included an impending rupture state of the aneurysm; jetting calcifications at the bifurcation; and, a concomitant thoracic aneurysm.The patient's use of antiplatelet therapy might have contributed to this event due to the associated increase risk for bleeding complications.Given the longevity of the device and the patient's medical history, there might have been disease progression and/or unresolved endotension that might have contributed to this event.The endoleak type iii and the secondary procedure were substantiated by medical documentation; however, specifically, a type iiib could not be substantiated.Medical documentation mentioned a type i and ii at the implant procedure, but could not be substantiated due to lack of information.The patient was discharged to rehabilitation post-operative day seven.A manufacturing record review was performed, the lot met all release criteria with no related issues or deviations that would explain the reported event.The lot usage history showed all units have been consumed and no other units 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, an exact root cause could not be determined based upon available information.However, the use of a device in a greater than 60 degree angle (off-label) might have contributed to this event along with the patient's use of antiplatelet therapy due to the associated increase risk for bleeding complications.Given the longevity of the device and the patient's medical history, there might have been disease progression and/or unresolved endotension that might have contributed to this event.

• Brand Name: AFX SYSTEM
• Type of Device: SUPRARENAL PROXIMAL EXTENSION 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 ; 9495957287
• MDR Report Key: 4210439
• MDR Text Key: 4965847
• Report Number: 2031527-2014-00303
• 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: 09/29/2014

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: 05/31/2012
• Device Model Number: A25-25/C95-O20
• Device Lot Number: W11-2908-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR