MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-80/I16-40

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Material Integrity Problem (2978)

Patient Problems Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 02/08/2020

Event Type  Death  

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.Device iteration is afx with strata.Devices remain implanted in patient.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately seven and a half (7.5) years post initial procedure, the patient presented emergently with a type iiib endoleak.While driving to the hospital the patient was involved in a car accident and thus arrived by ambulance.The physician elected to treat the patient by relining using an endurant (non-endologix) stent graft.The patient reportedly had no issues and made it through the procedure in good condition.However, the physician reported the patient later died due to trauma and a subarachnoid hemorrhage from the vehicle accident.

Manufacturer Narrative

Clinical assessment was completed based on the received medical records.The reported type iiib endoleak of the afx bifurcated stent graft is confirmed.The causation of the type iiib endoleak was indeterminate.The death complaint is unconfirmed due to a lack of relevant medical records.Additionally, clinical assessment determined that there was evidence to reasonably suggest rupture occurred that was not included in the event as reported.Device, user, procedure or anatomy relatedness of this event could not be determined.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.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.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.Device iteration is afx with strata.Corrections: b5: describe event or problem ¿ updated.H6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately seven and a half (7.5) years post initial procedure, the patient presented emergently with a type iiib endoleak.While driving to the hospital the patient was involved in a car accident and thus arrived by ambulance.The physician elected to treat the patient by relining using an endurant (non-endologix) stent graft.The patient reportedly had no issues and made it through the procedure in good condition.However, the physician reported the patient later died due to trauma and a subarachnoid hemorrhage from the vehicle accident.Additionally, clinical assessment determined that there was evidence to reasonably suggest rupture occurred that was not included in the event as reported.It should be noted that the primary device was previously reported under mfr# 2031527-2016-00481 for a type iiia endoleak that was treated with implant of an afx vela suprarenal and an afx vela infrarenal.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9814304
• MDR Text Key: 182890100
• Report Number: 2031527-2020-00088
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1030878-010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX SUPRARENAL AORTIC EXTENSION 1031350-022; AFX VELA INFRARENAL (LN 1484368021); AFX VELA SUPRARENAL (LN 1484368021)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR