MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Occlusion Within Device (1423); Malposition of Device (2616)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994)

Event Date 01/03/2018

Event Type  Injury  

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 Description

Patient initially implanted with an afx2 bifurcated an two vela infrarenal.Recently, patient presented emergently with stomach pain.Ct imaging showed an endoleak type iiib and increase in aneurysm size.The physician elected to place another main body and cuff to successfully seal the leak.Patient was reported as being stable post repair.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type iiib of the main body, sac growth, emergent presentation, and secondary procedure.Additionally there was evidence to reasonably support the following observations; endoleak type ia (will be reported in a separate report), endoleak type ib of the left limb, near complete collapse of the superior sent margin of the main body with occlusive thrombus, incorrect placement of both suprarenal cuffs, and arterial filing in the distal inferior vena cava.The most likely cause of the compromised stent graft integrity of the main body was the placement of cuffs outside to of the main body stent at time of the implant which resulted in the near collapse of the superior stent margin of the main body with occlusive thrombus.The most likely cause of the distal left loss of seal could not be determined due to lack of imaging surrounding the implant procedure.No procedure related harms detected, however the abnormal arterial filling of the distal vena cava might indicate a pre-existing or a creation of an av fistula during the repair procedure.The final patient disposition could not be ascertained due to lack of medical information surrounding the secondary endovascular procedure.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7206315
• MDR Text Key: 97767357
• Report Number: 2031527-2018-00046
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)170318
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

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
• Device Operator: Physician
• Device Expiration Date: 03/18/2017
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 1356565018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL-LOT: 1252087012; VELA SUPRARENAL-LOT: 1472865014; VELA SUPRARENAL-LOT: 1252087012; VELA SUPRARENAL-LOT: 1472865014
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR