MAUDE Adverse Event Report: ENDOLOGIX INC. INTUITRAK; BIFURCATED STENT GRAFT

Model Number 25-16-120BL - INTUITRAK

Device Problems Hole In Material (1293); Leak/Splash (1354); Torn Material (3024)

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

Event Date 11/04/2017

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 two infrarenal aortic extensions.On (b)(6) 2011 the patient was reported to have had a secondary procedure to treat a possible type 1b endoleak or iliac aneurysm growth.On (b)(6) 2017 a follow up computed tomography (ct) showed the patient had a tear in the bifurcated stent and aneurysm sac growth.The physician is planning to repair the endoleak.A secondary to date has not been scheduled or completed.The patient is currently reported to be in good condition and 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 was unconfirmed reports to find substantial evidence to support the following reported events for the type iiib endoleak of the main body.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 compromised stent graft integrity of the main body was either the burden of the multiple proximal extensions stents due to a hostile neck anatomy or the multiple distal iliac extensions upon the main body stent.Notably, there were bare metal stents in the proximal and distal areas.The most likely cause of the proximal loss of seal was the hostile neck anatomy.In addition, the most likely cause of the distal loss of seal was the tortuous iliac anatomy combined with suboptimal placement of the iliac stent with in the band at the implant.Additional findings were noted at 25 month post implant, in which patient had a coiling procedure done to address a type 1a endoleak that was corrected with a non-endologix stent, along with a non-endologix limb placement for a type 1b endoleak.At 35 months post implant, patient had a open repair done for the type 1a endoleak with a dacron tape procedure.The procedure related harms could not be ascertain due to lack of medical information surrounding the event.There was no evidence of a secondary procedure.However, it was reported that the patient condition is stable.To date there has been no reports of further negative patient condition.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: INTUITRAK
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7068731
• MDR Text Key: 93281313
• Report Number: 2031527-2017-00644
• 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: 11/04/2017

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: 03/31/2010
• Device Model Number: 25-16-120BL - INTUITRAK
• Device Lot Number: W09-1102-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 11/04/2017
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2009
• 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: 85 YR