MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and (2) vela suprarenal stent graft extensions to treat an abdominal aortic aneurysm.Approximately 4.5 years post initial procedure, during a routine follow up a type 1a endoleak was identified.Patient is stable and will continue to be monitored.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and (2) vela suprarenal stent graft extensions to treat an abdominal aortic aneurysm.Approximately 4.5 years post initial procedure, during a routine follow up a type 1a endoleak was identified.Patient is stable and will continue to be monitored.Subsequent to the initial report, the discharge summary from the initial procedure was received providing additional information.The initial procedure was outside the indications of use (off- label) as the patient presented with severe aortoiliac disease and stenosis of the ostial portion of bilateral common iliac arteries.Additionally, after implant of the afx devices, additional stenting of the suprarenal portion was performed with a palmaz (non-endologix) extension (off label use of concomitant devices).An additional medtronic visipro (non-endologix) was implanted in the left common iliac artery.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ia endoleak was unconfirmed due to a lack of relevant medical records and imaging as only the discharge summary from the initial procedure was provided.Definitive device, user, procedure or anatomy relatedness of this event could not be determined.However; a non endologix stent was placed in the proximal neck and could have contributed to the reported event (concomitant product use is off ifu).The final patient status was reported to be pending a secondary endovascular procedure.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9955497
• Report Number: 2031527-2020-00134
• Device Sequence Number: 2438109
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)180310
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 02/19/2018
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1252067024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/23/2020
• 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 (LN 1252333030); AFX VELA INFRARENAL (LN 1252180023); AFX VELA SUPRARENAL (LN 1252067024); MEDTRONIC VISIPRO (LN A082769); PALMAZ (LN N1014300)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR