MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20 V

Device Problem Material Puncture/Hole (1504)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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.Device remains implanted.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a type 3b endoleak of the suprarenal stent graft was identified during a routine follow up.An intervention is being planned.As of the date of this report, there have been no additional patient sequelae reported.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a type 3b endoleak of the suprarenal stent graft was identified during a routine follow up.An intervention is being planned.As of the date of this report, there have been no additional patient sequelae reported.Additional information: the physician completed a re-intervention and elected to treat the patient with two (2) vela infrarenal stent grafts.The final patient status was not reported.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was unable to find substantial evidence to support the reported event of the type 3b endoleak based on the medical imaging available for review.Procedure related harms, device, user, or anatomy relatedness of this event could not be determined.The final patient status post secondary endovascular procedure was not reported.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
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9527181
• MDR Text Key: 188559603
• Report Number: 2031527-2019-00622
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)190616
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1484368-020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT, LOT 1519220005
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR