MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number A28-28/C95V

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Thrombosis (2100); Stenosis (2263); Claudication (2550)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

An afx bifurcated, vela suprarenal extension, and 1 iliac limb was implanted to treat an abdominal aortic aneurysm.The 3 year follow-up showed the presence of device thrombosis and proximal endograft collapse.A reintervention is planned at a later date to reline the device, but has not yet been scheduled.As of the date of this report, the patient condition is reported as stable and there have been no additional patient sequelae reported.

Manufacturer Narrative

Based on the clinical assessment for this event, the most likely cause of the loss of seal and stent graft compression was found to be user related due to the off-label proximal neck.The 71 degree infrarenal neck angulation and significant proximal neck thrombus (cautionary use condition) likely contributed to the event.The final patient disposition is unknown following the secondary endovascular procedure, however, there have been no further reports of patient sequelae.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• Brand Name: AFX
• Type of Device: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 7051166
• MDR Text Key: 92715186
• Report Number: 2031527-2017-00637
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2015
• Device Model Number: A28-28/C95V
• Device Lot Number: 1247597028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR