MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Loss of or Failure to Bond (1068); Collapse (1099); Fracture (1260); Misconnection (1399); Use of Device Problem (1670)

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

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately seven (7) years post initial procedure, a type iiia endoleak with component separation, stent collapse, and aneurysm enlargement (to 8cm) were detected.The physician elected to treat the patient by implanting an infrarenal afx device on (b)(6) 2019.The patient was stable when leaving the operating room.There have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of aneurysm sac growth due to a lack of comparative imaging.There was substantial evidence, however, to support the reported type iiia endoleak of the aortic components, and resultant stent cage collapse of the bifurcated device.The clinical assessment also determined that there was evidence to reasonably suggest a strut fracture of the bifurcated device occurred that was not included in the event as reported; the fracture was discovered during review of the 84-month post-implant ct scan.The type iiia endoleak and subsequent stent cage collapse events are most likely anatomy-related due to aortic remodeling.In addition, the revision of previously placed stent grafts in 2014 with non-endologix devices also likely contributed to this event.Procedure-related harms for this complaint could not be determined.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

Event Description

Additional information received per clinical assessment confirming that strut fracture of the bifurcated device was also present at the time of the reported event.Clinical also discovered a previous revision procedure performed in 2014 with non-endologix devices (off-label use).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8292596
• MDR Text Key: 134589164
• Report Number: 2031527-2019-00068
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: BA28-100/I16-40
• Device Lot Number: W11-3743-002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX-INFRARENAL AORTIC EXTENSION: W11-2806R-014; AFX-SUPRARENAL AORTIC EXTENSION: W11-3164R-021; AFX-INFRARENAL AORTIC EXTENSION: W11-2806R-014; AFX-SUPRARENAL AORTIC EXTENSION: W11-3164R-021
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR