MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTA UNI-ILIAC

Model Number A28-28/C75-O20

Device Problems Failure To Adhere Or Bond (1031); Burst Container or Vessel (1074); Migration or Expulsion of Device (1395); Stretched (1601); Pressure Problem (3012)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Rupture (2208)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.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 and a suprarenal aortic extension on (b)(6) 2011.Patient came in emergently with a rupture and possible type 3a endoleak.The physician treated the patient by implanting a competitor device and completing a fem-fem bypass.The patient is stable.

Manufacturer Narrative

Additional information was found from a computed tomography (ct) review that the patient had an endoleak ii along with stent migration and partial stent collapse.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5453777
• MDR Text Key: 38776598
• Report Number: 2031527-2016-00069
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: A28-28/C75-O20
• Device Lot Number: W11-3697-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2011
• 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: 89 YR