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

Model Number	BA25-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/19/2018
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
An afx bifurcated, vela suprarenal and infrarenal extension, and one (1) iliac limb was implanted to treat an abdominal aortic aneurysm.It was noted that during the index procedure, a flared iliac limb was placed with the intent of coiling at some point in the future.The physician decided its time as the right iliac aneurysm is growing.A secondary procedure was completed on (b)(6) 2018, the physician elected to implant three ovation iliac limbs.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there was unsubstantial evidence to support the following reported events; a iliac aneurysm enlargement and a secondary procedure.The most likely cause of the distal right loss of seal was the off-label iliac anatomy even with an off-label use of infra-renal stent in the right common iliac artery.No procedure related harms detected.The final patient disposition could not be ascertained due to lack of medical information surrounding the discharge procedure.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The manufacturing records confirm that the lots met all requirements prior to release.Device remains implanted in the patient and was not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7421540
• Report Number: 2031527-2018-00295
• Device Sequence Number: 37796
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)171212
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/19/2018

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: Physician
• Device Expiration Date: 12/12/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1283305016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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: AFX-LIMB: LOT: 1253183022; VELA INFRARENAL: LOT: 1252140016; VELA SUPRARENAL: LOT: 1342235004; AFX-LIMB: LOT: 1253183022; VELA INFRARENAL: LOT: 1252140016; VELA SUPRARENAL: LOT: 1342235004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR