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

Model Number A34-34/C100-O20

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A follow up showed the patient had aneurysm sac growth and a possible type 3b endoleak in the proximal extension.There was no contrast noted outside the graft, however, the proximal extension was dilated to 40mm.The physician is planning to reline the initial implanted devices.A secondary intervention has not been carried out or reported to the endologix.The patient status is currently unknown and not initially reported.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a sac growth.The reported type 3b endoleak of the cuff was refuted and there was no overt angiography evidence of type 3b endoleak (type v endoleak), and stent cage was found to be only 13% stretched.A secondary was performed on (b)(6) 2017.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the proximal loss of seal was the off label neck anatomy, the most likely cause of the stent cage dilation (13%) of the cuff stent was the use of strata material.To date there has been no reports of further negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.Device code: (b)(4).

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7166466
• MDR Text Key: 96444451
• Report Number: 2031527-2018-00011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1054959-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2012
• 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): Other
• Patient Age: 76 YR