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

Model Number BA25-110/I16-30

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

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

Event Date 12/17/2017

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 ct showed the patient had aneurysm sac growth and a type 3b endoleak.The physician is planning a secondary intervention.A secondary has been scheduled for a future date.The patient is reported to be in stable condition and no additional adverse events have been reported.

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 of a damage to the sheath.Clinical was able to confirm the type iiib endoleak of the main body; the sac growth; and the secondary endovascular procedure done on (b)(6) 2018.In addition, there was also main body stent cage dilation (41.9mm, 66%).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(stretched [66%] and breached) is the use of the strata material in combination with the off-label use with oversized cuff.Procedure-related harms and final patient disposition could not be ascertained due to the lack of the medical information surrounding the secondary repair procedure.To date there has been no reports of further negative patient sequelae.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; 1.Upgraded graft material (i.E.Duraply) and 2.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%.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

Event Description

On (b)(6) 2018, endologix was made aware of a secondary procedure performed on (b)(6) 2018 to correct the type 3 endoleak.No further information was provided on patient condition post op surgery.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7198598
• MDR Text Key: 97474129
• Report Number: 2031527-2018-00039
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2017

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: 03/31/2014
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1101368-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 12/17/2017
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION- 1047250-028; SUPRARENAL AORTIC EXTENSION- (B)(4)
• Patient Outcome(s): Other
• Patient Age: 74 YR