MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Burst Container or Vessel (1074); Stretched (1601); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problems Aneurysm (1708); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Rupture (2208); Blood Loss (2597)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Patient initially implanted with a bifurcated stent, a suprarenal aortic extension and a limb extension on (b)(6) 2012.Patient had a follow up computed tomography (ct) on (b)(6) 2014 that showed a type 3a endoleak.The physician implanted an infrarenal aortic extension to resolve the leak.Patient admitted emergently on (b)(6) 2016 with a contained rupture.The patient had an open repair procedure and the implants were explanted.Patient is in stable condition.

Manufacturer Narrative

Clinical evaluation could not confirm the rupture or the explant due to limited medical records.However, an unknown endoleak was confirmed.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.Devices were not returned and remain implanted.The root cause is inconclusive, there is not enough information to determine the root cause of the reported event.Potential contributing factors to the reported event include; off label, severe lateral remodeling of the system, irregular stent pattern of the cuff seen at index (possible deployment between a strut of the main body stent) and the prior repair of a el3a with a bare metal stent, and a possible crushing of the initial cuff might have contributed to the possible change in stent integrity of the main body (hyper-dilation).

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5510660
• MDR Text Key: 40682620
• Report Number: 2031527-2016-00108
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1041709-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2012
• 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: 71 YR