MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; VELA SUPRARENAL

Model Number	A25-25/C75-O20V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/22/2018
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
Patient was initially implanted with an afx bifurcated, and two vela suprarenal device.During a routine follow up, it was noted that the patient had and endoleak type ia and the proximal extension has moved down.The physician elected to place another proximal extension to successfully resolve the leak.Patient doing fine post secondary procedure.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported secondary endovascular procedure.Clinical evaluations was unable to find substantial evidence to support the following reported events; type ia endoleak, supra renal cuff movement.The most likely cause of the proximal loss of seal, the caudal movement of the cuff, procedure related harm and final patient disposition could not be determined due to lack of the medical information surrounding the implant procedure and the secondary endovascular procedure.To date there has been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7274115
• Report Number: 2031527-2018-00094
• Device Sequence Number: 11056917
• Product Code: MIH
• UDI-Device Identifier: 00818009013576
• UDI-Public: (01)00818009013576(17)150312
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/22/2018

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: 03/12/2015
• Device Model Number: A25-25/C75-O20V
• Device Lot Number: 1229342009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 04/11/2018
• 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-BIFURCATED-LOT: 1070993-001; VELA SUPRARENAL-LOT: 1229342025; AFX-BIFURCATED-LOT: 1070993-001; VELA SUPRARENAL-LOT: 1229342025
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR