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

Model Number A34-34/C80-O20V

Device Problem Leak/Splash (1354)

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

Event Date 12/17/2014

Event Type  malfunction  

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: adequate medical documentation and suboptimal imaging studies were available for this review.Product use was incongruent with the ifu due to the 29% change in the aortic neck diameter and greater than 90 degree angulation of the left common iliac artery.Cautionary product use conditions that might have contributed to this event included: bilateral iliac artery tortuosity and the moderate-severe calcifications.Intraoperatively, there was evidence to support a type ia endoleak intra-operative for which an additional vela stent was placed.One month post implant, there was evidence to support an unknown endoleak; a differential diagnosis between a type ia or ii endoleak could not be established.There was no evidence of rendered treatment.The final patient disposition could not be established, but the aneurysm sac was noted to be decreasing in size on the last known ct scan.Reportedly, the patient is stable.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 determined based upon available information.

Event Description

It was reported that approximately 1 month post implant of a bifurcated device and a suprarenal aortic extension, the patient was seen for a routine follow-up.A computed tomography scan revealed an endoleak.The physician has elected to watch the patient for a month and then perform a secondary intervention.The patient is currently stable.

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.

• 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 ; 9495984611
• MDR Report Key: 4372402
• MDR Text Key: 18462248
• Report Number: 2031527-2014-00420
• 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: 12/17/2014

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: 05/13/2015
• Device Model Number: A34-34/C80-O20V
• Device Lot Number: 1250755-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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: 80 YR