MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

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

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

Event Date 12/09/2015

Event Type  Death  

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.Additional device: model bifurcated, lot: w11-4077-016, rel.Date: 9/06/2011, exp.Date: 7/31/2012.Limb aortic extension, lot: w11-2956-002, rel.Date: 6/30/2011, exp.Date: 5/31/2014.

Event Description

It was reported the patient had a procedure on (b)(6) 2011 with a bifurcated, a suprarenal and a limb aortic extension.Subsequently, the computed tomography scan showed the patient had el3a and was to be evaluated and repaired by (b)(6) 2015.On (b)(6) 2015 the patient admitted to the emergency room required resuscitations and ventilation.The physician thought the patient had rupture and few hours later patient passed away in the emergency room.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5351486
• MDR Text Key: 35287306
• Report Number: 2031527-2016-00002
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2014
• Device Model Number: A34-34/C80-O20
• Device Lot Number: W11-4583-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2013
• 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: 76 YR