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

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Renal Failure (2041); Stenosis (2263)
Date of Event	08/17/2017
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
The patient was initially implanted with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.On (b)(6) 2017 it was reported the patient had a renal artery occlusion due to possible stent movement.A secondary intervention has not been reported.There have been no additional adverse events reported for this patient.The current patient status is unknown.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical assessment refuted device migration and concluded there was a malposition of the suprarenal cuff.Additionally the clinical evaluation found atrophy of the right kidney, right renal artery stenosis from the stent fabric placement of a stent in the left renal artery.The most likely cause of the device encroachment was user-error; the fabric of the suprarenal cuff appeared to be placed above the renal ostia during the implant procedure.There was no evidence migration.The devices remain implanted in the patient and were not available for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6985490
• Report Number: 2031527-2017-00556
• Device Sequence Number: 1117965
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)191220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 12/20/2019
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1629080-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/29/2017
• 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: Other
• Patient Age: 68 YR