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

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was initially implanted with a two suprarenal aortic extensions, an infrarenal aortic extension, a bifurcated stent, and a limb stent.The initial implant procedure included the placement of one of the suprarenal aortic extensions in the inferior vena cava (ivc).On (b)(6) 2016 the patient had a type 2 endoleak that was monitored by the physician with the possibility of a coil embolization procedure.A secondary procedure was not reported to endologix.On (b)(6) 2017 it was reported the patient had a type 1b endoleak.The physician elected to implant an additional limb extension in the right iliac artery to seal the endoleak.During the procedure the wire manipulation during the delivery of the limb extension caused an intraoperative unknown endoleak in the distal aorta between the left iliac limb of the main body and the initial left iliac limb extension.The physician implanted an additional bifurcated stent, a non-endologix palmaz stent inside the newly placed bifurcated stent and an additional limb extension in the left iliac artery.At the completion of the secondary procedure there were no endoleaks observed.The patient is reported as doing well post procedure.There have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7208607
• Report Number: 2031527-2018-00049
• Device Sequence Number: 11000127
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)180715
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1370955-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: 77 YR