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

Model Number BA22-90/I16-30

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 11/07/2014

Event Type  Injury  

Event Description

It was reported that approximately 26 months post implant of a bifurcated device, two limb stent grafts, and suprarenal aortic extension, the patient presented to the hospital and was symptomatic with abdominal pain and hypotension.The hospital performed a computed tomography scan which indicated the patient had a rupture and an endoleak.The physician elected to perform a secondary procedure and implanted a competitor device to repair the rupture and endoleak.The patient is reported to be 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 in the 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: there was adequate medical documentation and there were suboptimal imaging studies available for this review.Product use was incongruent with the ifu due to the reported left iliac artery diameter of greater than 2.3 cm.The patient's use of antiplatelet therapy might have contributed to this event due to the increased risk for bleeding complications.Disease progression might have also contributed to this event.There was substantiated medical documentation evidence of a type ii endoleak from the left hypogastric artery one-month post implant, and a subsequent procedure of a left hypogastric coiling (unknown date).Twenty-six months post implant, there was substantiated evidence of a: rupture; anterior type iiib endoleak; an unknown endoleak (type ib or possibly a type ii endoleak) of the left iliac artery; and, a second, subsequent procedure of an evar repair.The available ct images were delayed phase only; there might have been evidence of an additional left latero-posterior type ii endoleak of the mid aorta due to the preponderance of a contrast pool on these images.A complication of an embolectomy and a second subsequent procedure of an embolectomy and resection of the left common femoral artery were also substantiated.The patient was discharged home on the tenth post-operative day.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 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 on the investigation findings a root cause could not definitely be determined, but clinical review showed off-label use of the device where the left iliac artery diameter was greater than 2.3 cm.The patient's use of antiplatelet therapy might have contributed to this complaint due to the increased risk for bleeding complications.Disease progression might have also contributed to this complaint.The exact cause of the type iiib endoleak could not be determined.(b)(4).

• 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: 4303189
• MDR Text Key: 5270328
• Report Number: 2031527-2014-00367
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/27/2012
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1044223-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2012
• 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: 66 YR