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

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
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.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial implant with a bifurcated stent and a suprarenal aortic extension.On (b)(6) 2016 computed tomography (ct) showed aneurysm sac growth, loss of overlap between the proximal extension and the main body as well as unintended movement of the proximal extension.The patient refused treatment at the time and a secondary intervention was not completed.On (b)(6) 2016 the patient had a secondary intervention and the physician elected to reline the initial devices by implanting an additional bifurcated stent and a suprarenal aortic extension.A follow up ct completed on (b)(6) 2017 showed additional aneurysm sac growth.The physician is planning an additional repair procedure, a subsequent endovascular procedure has not been scheduled.The patient is reported to be asymptomatic and doing well.
Additional Manufacturer Narrative
(b)(4).Based on the available information, the root cause of the reported event was likely due to the loss of overlap and unintended movement of the proximal extension.Clinical review found evidence of a secondary relining with an afx main body and suprarenal proximal extension, and that the aneurysm growth was 4mm.The manufacturing lot evaluation record review confirmed all devices met specifications prior to release.Device remains implanted in the patient and was not returned, therefore no physical evaluation was completed.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6474622
• Report Number: 2031527-2017-00149
• Device Sequence Number: 10845915
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)170412
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2017

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: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: BA28-90/I16-30
• Device Lot Number: W11-3622-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 04/09/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT- (B)(4); SUPRARENAL AORTIC EXTENSION- (B)(4); VELA SUPRARENAL- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR