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

Model Number A28-28/C95-O20

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Material Puncture/Hole (1504); Stretched (1601)

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was implanted with an afx bifurcated stent graft and suprarenal aortic extension on (b)(6) 2013.During standard follow-up, the patient was noted to have an endoleak at an unknown source, but was asymptomatic.The physician suspected this was a type 2 endoleak at that time.On (b)(6) 2018, prior to the secondary procedure being completed and in the operating room, the physician performed an angiogram which confirmed a type 3 endoleak at the proximal cuff.The secondary case for this patient was completed on (b)(6) 2018 and the patient was relined with an afx vela infrarenal.This procedure was completed without incidence, a satisfactory seal was achieved, and the patient returned home the following day.No devices were explanted during this re-intervention.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: type iiib endoleak of the cuff.The complaint is most likely device related (use of strata material).The clinical assessment also determined that there was evidence to reasonably suggest 69% stent cage dilation of the cuff (stretched and breached) occurred which was not included in the event as reported.The rupture was discovered during review of the 60 month post implant ct scan.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable discharged on the first post-operative day.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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 (b)(6) 2014.The type 3b 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 less than 0.2%.(b)(4).

Event Description

Additional information received confirming that the reported endoleak was suspected as a type iiib at the proximal cuff.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445889
• MDR Text Key: 106004847
• Report Number: 2031527-2018-00289
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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: Physician
• Device Expiration Date: 11/30/2012
• Device Model Number: A28-28/C95-O20
• Device Lot Number: W11-6238-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT - LOT W116322008; AFX-BIFURCATED STENT GRAFT - LOT W116322008
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR