MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I16-55

Device Problems Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 02/17/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains 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 implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately six (6) years post initial procedure, a type 3b endoleak was identified.A secondary procedure was completed.The physician elected to reline the original implanted devices with another bifurcated stent graft and a suprarenal stent graft extension to resolve the reported event.The patient was reported as doing excellent post intervention.

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.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of; a type 3 endoleak with a rupture and stent cage dilation.Procedure related harms of this complaint could not be determined with the medical records available for review.The final patient status was reported to be excellent.The type 3b endoleak and the stent cage dilation are most likely device related due to use of strata material.The rupture and intervention is related to the 3b endoleak.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with strata.

Event Description

Additional information: during our investigation, an aorta rupture and stent cage dilation of the bifurcated stent graft were also identified.These events are related to the already reported 3b endoleak.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8430949
• MDR Text Key: 139161564
• Report Number: 2031527-2019-00130
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: BA25-80/I16-55
• Device Lot Number: W11-3463R-012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: SUPRARENAL EXTENSION, LOT 1026369-047
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR