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

Model Number BA28-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Burst Container or Vessel (1074); Hole In Material (1293); Stretched (1601); Pressure Problem (3012)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 12/23/2015

Event Type  Death  

Manufacturer Narrative

To date the incident sample has been received for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Additional devices: suprarenal aorta uni-iliac: model: a34-34/c100-020, lot number: w11-4432-024, lot release date: 09/28/2011, lot expiration date: 08/31/2012 ; suprarenal aorta uni-iliac: lot number: w11-2660r-005, lot release date: 04/30/2012, lot expiration date: 04/30/2014 ; infrarenal aorto uni-iliac: lot number: w11-4711-007, lot release date: 10/13/2011, lot expiration date: 8/31/2012.

Event Description

It was reported the patient had an initial procedure on (b)(6) 2012 with a bifurcated device, a suprarenal and an infrarenal aortic extension.On (b)(6) 2012 patient admitted emergently for suspected 1b endoleak.The endoleak could not be confirmed and the physician elected to implant a new suprarenal aortic extension, post procedure the physician confirmed no leaks were present.A follow-up in (b)(6) 2014 showed an aneurysm sac increase with possible type ii endoleak.The patient was referred to another physician for treatment.On (b)(6) 2015 patient admitted to the emergency room with emergent-rupture.The implant appeared to be disconnected and aortic extension was protruding through the aorta, it was also noted that the tissue surrounding the renals was degraded.The physician elected to explant and attempt an open repair.The procedure was completed and the patient was transferred to the icu post op.However, the patient expired in post op.

• 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: 5385589
• MDR Text Key: 36641448
• Report Number: 2031527-2016-00023
• 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
• Report Date: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: BA28-90/I16-30
• Device Lot Number: W11-4971-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2011
• 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): Death
• Patient Age: 86 YR