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); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	04/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was originally implanted with an afx bifurcated stent graft and a vela infrarenal on (b)(6) 2014.A follow-up ct scan detected occlusion of the proximal extension and a small flow lumen going behind the occluded proximal extension and flowing back into the main body, perfusing the lower extremities; this is categorized as an endoleak from an indeterminate origin.The physician has elected to treat the patient by mechanical thrombectomy of the extension and addition of a proximal extension, with re-intervention scheduled for (b)(6) 2018.The patient is currently reported to be stable and asymptomatic.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on 04/25/2018 and the required images were not received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received indicating that the surgeon tried to drip tpa overnight to dissolve the clot in the proximal extension.This was unsuccessful, and surgery for new extension was cancelled.Patient is asymptomatic.Physician felt that if the patient became symptomatic, or begun to have claudication, would propose an intervention at that time.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7473475
• Report Number: 2031527-2018-00399
• Device Sequence Number: 106784
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)150305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2018

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: 03/05/2015
• Device Model Number: A34-34/C100V
• Device Lot Number: 1178434-026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2018
• Supplement Date Received by Manufacturer: 04/21/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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 STENT GRAFT - LOT 1053246-019; AFX-BIFURCATED STENT GRAFT - LOT 1053246-019
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR