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

Model Number A28-28/C95-O20 V

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Death (1802)

Event Date 10/16/2015

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 devices: model: a28-28/c95 v infrarenal aortic extension lot: 1164428-009 rel.Date: 3/13/2014 exp.Date: 2/11/2015.Model: ba25-90/i20-30 bifurcated lot: 1257009-009 rel.Date: 6/16/2014 exp.Date: 4/30/2017.

Event Description

It was reported that the patient had a procedure on (b)(6) 2014 with a bifurcated, a suprarenal, and an infrarenal aortic extension.On (b)(6) 2015 patient was admitted emergently with a component separation and rupture.Physician attempted to bridge the components with a competitor device and was unsuccessful and patient expired.

Manufacturer Narrative

Based upon the clinical assessment, the reported component separation and a type iiia endoleak was confirmed.Fifteen months post implant, there was evidence to support: a complete component separation; partial stent collapse of the main body; type iiia endoleak; slight progressive dilation of the superior stent margin of the main body stent to 3.5 cm, and rupture.The death, or cause of death could not be substantiated due to lack of information.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.Based upon the investigation findings, a design or manufacturing root cause was not be identified based upon the available information.However, factors that may have contributed to the event include: product use was incongruent with the ifu due to: the conical 26% change in the aortic neck diameter; aortic neck length less than 1.5 cm; and, the ruptured state of the left proximal aorta.Cautionary product use conditions that might have contributed to this event included: the severe calcifications at the aortic neck and iliac arteries; and the near 90° posterior angulation of the iliac arteries.Patient factors that might have contributed to this event included: antiplatelet therapy (aspirin).

• 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: henry to ; 2 musick; irvine, CA 92618 ; 9495984772
• MDR Report Key: 5225803
• MDR Text Key: 31259709
• Report Number: 2031527-2015-00449
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/20/2015
• Device Model Number: A28-28/C95-O20 V
• Device Lot Number: 1246587-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2014
• 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): Death
• Patient Age: 72 YR