MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-80/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2016
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
Patient initially implanted with a bifurcated stent on (b)(6) 2014, the patient had several non-endologix stents placed proximally to the main body.A routine follow up showed a potential separation of components.A preliminary clinical review identified a decrease in overlap between the main body and proximal extension, a complete component separation was not observed.During the same review two additional non-endologix stents were identified in the right and left iliacs.The patient has not been scheduled for a secondary procedure and is in stable condition.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was not able to confirm the reported stent movement.Additionally there was evidence to reasonably support the following observations; at 20 months post implant the patient received non-endologix fenestrated graft with fenestrations for the superior mesenteric artery and bilateral renal arteries, patient had significant stenosis of rra stent, overlap of the non-endologix proximal cuff and afx main body was approximately 1.8cm, bilateral non-endologix stents placed from each iliac limb ending just proximal to the common femoral arteries bilaterally.The clinical assessment was based on no medical records and suboptimal patient images.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.The root cause of the reported event is unknown, there is not enough information to determine the root cause of the reported event.The event devices remain implanted in the patient and were not returned for further evaluation.The clinical evaluation found further evidence to reasonably suggest the following contributing factors to the reported event; off label use and the concomitant use of a non-endologix fenestrated stent graft, patient anatomy, and a dilated superior stent margin of the main body might have contribute to decreasing and/or inadequate overlap.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5984628
• Report Number: 2031527-2016-00451
• Device Sequence Number: 13646857
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)170902
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2016

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: 09/02/2017
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1268473-021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 12/15/2016
• 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: NON-ENDOLOGIX STENT-PROXIMAL CUFF; NON-ENDOLOGIX-LIMB EXTENSION (LEFT); NON-ENDOLOGIX-LIMB EXTENSION (RIGHT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR