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

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2017
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
Patient was initially implanted with an afx bifurcated and vela suprarenal device.It was reported that the neck measurement might be off label.Approximately 3 years post implant, the patient presented with either an endoleak type 1a or 3a.On (b)(6) 2017 the physician elected to implant a non-endologix proximal cuff and the leak persisted.The patient was transferred to another hospital and under the care of another physician.The new physician elected to place another non-endologix and performed a chimney/snorkel on the right renal to successfully resolve the leak.No additional patient sequelae has been reported at this time.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to confirm the type 1a endoleak (suprarenal/cuff) and the secondary procedure.Clinical also found these additional findings; intraoperative 1a endoleak (suprarenal/cuff) that was treated with the bare metal stent.The most likely cause of the proximal loss of seal (type 1a endoleak) was the off label aortic neck and protruding calcifications (cautionary product use).There have been no further reports of negative patient sequelae.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: 7168374
• Report Number: 2031527-2018-00016
• Device Sequence Number: 1736743
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)150425
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/16/2017

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: Physician
• Device Expiration Date: 04/25/2015
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1246586-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2017
• Supplement Date Received by Manufacturer: 12/16/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 1055364-025; AFX-BIFURCATED-LOT: 1055364-025
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR