MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 10/03/2018

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

The patient was initially treated with an afx system in 2011.During a recent follow-up ct, it appears that the main body and proximal extension separated resulting in endoleak type iiia.In addition, the stent diameter of the proximal extension is measuring at 40mm resulting in an endoleak type iiib.The physician states the patient's aneurysm has been expanding over the last few follow-ups (timeframe and diameter unknown).The patient will be evaluated for possible conversion to open repair and continue to be monitored.As of this report, no additional patient sequelae have been 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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images but inadequate records were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8037507
• MDR Text Key: 126092812
• Report Number: 2031527-2018-00826
• 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: 10/03/2018

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: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: A34-34/C100-O20
• Device Lot Number: W11-5048-005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED-LOT: W11-5403-009; AFX-BIFURCATED-LOT: W11-5403-009
• Patient Outcome(s): Other
• Patient Age: 76 YR