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

Model Number BA28-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Stretched (1601); Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 04/05/2018

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 was initially implanted with an afx bifurcated and suprarenal device in 2012.Patient presented recently with an aneurysm growth found through an ultrasound.The physician noted that there was no obvious leak but there was fabric billowing.The patient also has a very tortuous aorta.The physician reported that this patient was treated over a year ago for an endoleak type ia that was not reported to endologix and will be reported in a separate report.The patient is currently doing well and will continue to be monitored.

Manufacturer Narrative

An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7497503
• MDR Text Key: 107687195
• Report Number: 2031527-2018-00411
• Device Sequence Number: 1
• Product Code: MIH
• 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: 04/08/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2012
• Device Model Number: BA28-100/I16-40
• Device Lot Number: W11-5296-017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL-LOT: W11-3798R-017; AFX-SUPRARENAL-LOT: W11-3798R-017
• Patient Outcome(s): Other
• Patient Age: 76 YR