MAUDE Adverse Event Report: ENDOLOGIX AFX; AORTO UNI-ILIAC (INFRARENAL)

Model Number A34-34/C100 V

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Date 10/08/2015

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.Additional devices: model: a34-34/c80-o20 suprarenal aortic extension, lot: 1045427-024, rel.Date: 02/12/2013, exp date: 12/31/2015.A28-28/c75o20 suprarenal aortic extension, lot: w11-4099r-022, rel.Date: 09/07/2011, exp date: 07/31/2012.

Event Description

It was reported that the patient had a procedure on (b)(6) 2012 with a bifurcated and a suprarenal aortic extension.Subsequently, patient had been seen twice before to correct a proximal endoleak.On (b)(6) 2013, physician implanted a suprarenal aortic extension to correct the leak.Then on (b)(6) 2014, an infrarenal aortic extension was implanted to correct another 1a leak.On (b)(6) 2015, physician noted that there was a component separation, causing a type 3a leak.On (b)(6) 2015, an infrarenal was implanted to correct the component separation.Patient is doing fine post procedure and no leaks were noted.

• Brand Name: AFX
• Type of Device: AORTO UNI-ILIAC (INFRARENAL)
• Manufacturer (Section D): ENDOLOGIX; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5346673
• MDR Text Key: 35214036
• Report Number: 2031527-2015-00520
• 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: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2015
• Device Model Number: A34-34/C100 V
• Device Lot Number: 1178434-011
• Other Device ID Number: 09013552(17)150305(21)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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: 84 YR