MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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.
Event or Problem Description
It was reported that the patient was initially implanted with a bifurcated device under off label condition on (b)(6) 2017.Approximately 3 months later, the patient was brought in and a vela infrarenal, an ovation extender, a cook thoracic stent, and two renal snorkels were placed.At the end of the procedure, a leak was still present.The patient was brought back in on (b)(6) 2017 and an aortic cuff was placed between the afx bifurcated stent and the cook thoracic stent.Patient is reported as being stable and there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; persistent proximal gutter leak (into both true and false lumens), two subsequent endovascular repairs for a proximal gutter leak and an endoleak type ib from the left common iliac artery in (b)(6) of 2017, and for a persistent proximal gutter leak in (b)(6) of 2017.Additionally there was evidence to reasonably support the following observations; sac growth, bilateral endoleak type ib from the common iliac artery, gutter leak(endoleak type ia) in both the true and false lumen, endoleak type ii which occurred subsequent planned phase ii procedure on month four, persistent proximal gutter leak endoleak post phase ii of a stepped repair.The most likely cause of the proximal non sealing of the aneurysm was the off label aortic neck in combination with the pre-existing aorto-iliac dissection.The most likely cause of the distal loss of seal was the off label iliac anatomy.Procedure-related harms included bilateral groin and left axilla seromas; the left groin required surgical drainage.The use of long-term antiplatelet therapy likely contributed to the procedure-related type ii endoleaks.There have been no reports of further negative patient sequelae, however, it was noted that there was a persistent proximal leak, although minimized, after the second intervention - essentially, the aneurysm was never completely mitigated.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6860683
• Report Number: 2031527-2017-00461
• Device Sequence Number: 706211
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)200223
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/23/2020
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1657484-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR