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

Model Number BA22-100/I13-40

Device Problems Burst Container or Vessel (1074); Hole In Material (1293); Leak/Splash (1354)

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

Event Date 07/10/2016

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.Devices remain implanted in the patient.

Event Description

It was reported that the patient had an initial procedure at an unknown date with afx devices.Subsequently, the patient presented to the emergency room on (b)(6) 2016 with an aneurysm rupture.Physician elected to do an open repair where a possible endoleak type 3b was noted.Patient expired during the procedure.

• 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: 5873664
• MDR Text Key: 52056648
• Report Number: 2031527-2016-00396
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO40002
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BA22-100/I13-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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