MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA25-60/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/19/2016
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
It was reported the patient had an initial implant on (b)(6) 2015 with a bifurcated stent and suprarenal aortic extension.On (b)(6) 2016 computed tomography (ct) \showed aneurysm sac growth with no endoleak seen.The patient is in stable condition and there are no reports of a secondary intervention being planned or scheduled.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information provided, the clinical evaluation was able to confirm the aneurysm sac growth from an accessory superior mesenteric artery (sma).The clinical evaluation additionally found the following potential contributing factors to the reported event; accessory sma vessel and anticoagulation therapy.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.
Event or Problem Description
Additional information received, a clinical evaluation found the patient returned to the hospital two times on (b)(6) 2015 and (b)(6) 2015, post initial procedure for bleeding from the access site.Patient was treated and released from the hospital.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6265424
• Report Number: 2031527-2017-00040
• Device Sequence Number: 16378292
• Product Code: MIH
• UDI-Device Identifier: 00818009010209
• UDI-Public: (01)00818009010209(17)171007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2016

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: 10/07/2017
• Device Model Number: BA25-60/I16-40
• Device Lot Number: 1283098-004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 05/04/2017
• 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: AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR