MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); No Information (3190)
Date of Event	04/28/2017
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
On (b)(6) 2015, the patient was initially implanted with an afx bifurcated stent graft and 1 vela infrarenal.On (b)(6) 2017, a secondary procedure, was performed for an unknown reason.During the intervention, 2 additional vela infrarenals and 1 vela suprarenal were implanted.No additional event or patient information is available.
Additional Manufacturer Narrative
A device malfunction, procedure related harms and the final patient disposition could not be determined due to a lack of any medical records or imaging.There have been no further reports of negative patient sequelae.(b)(4).

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7444247
• Report Number: 2031527-2018-00337
• Device Sequence Number: 11192237
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)170717
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

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: 07/17/2017
• Device Model Number: A34-34/C100V
• Device Lot Number: 1252524008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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: VELA INFRARENAL-1252524008
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR