MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number	BA25-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Intimal Dissection (1333); Failure of Implant (1924)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
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
It was reported the patient had a procedure on (b)(6) 2015 with a bifurcated device vela infrarenal and vela suprarenal aortic extension.Upon follow-up, computed tomography revealed that the patient had a leak and aneurysm growth.Patient is stable.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was able to confirm the reported event.There were no patient medical records available for review.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.Limited patient records were available and the device was not returned for further evaluation.Potential contributing factors to the reported event include; patient anatomy.
Event or Problem Description
The physician was able to seal the endoleak by implanting a non-endologix stent on (b)(6) 2016.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5637423
• Report Number: 2031527-2016-00197
• Device Sequence Number: 477275
• Product Code: MIH
• UDI-Device Identifier: 00818009010100
• UDI-Public: (01)00818009010100(17)170618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2017
• Device Model Number: BA25-70/I16-30
• Device Lot Number: 1260699-009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 07/26/2016
• 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: 67 YR