MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

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

Patient Problems Death (1802); Failure of Implant (1924); Heart Failure (2206); Rupture (2208)

Event Date 01/31/2020

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.

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, the patient presented with a type ii endoleak which was treated by coiling in (b)(6) 2019.Another two (2) months later, patient presented with an enlarged aneurysm (5cm to 9cm) and types ii, ia, and iii endoleaks.The physician elected to treat the patient by explanting the devices on (b)(6) 2020, at which time pin holes (type iiib endoleak) were identified in the distal portion of the bifurcated device.The patient is reportedly in stable condition.As of date, there have been no additional patient sequelae reported.

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, the patient presented with a type ii endoleak which was treated by coiling in (b)(6) 2019.Another two (2) months later, patient presented with an enlarged aneurysm (5cm to 9cm) and types ii, ia, and iii endoleaks.The physician elected to treat the patient by explanting the devices on (b)(6) 2020, at which time pin holes (type iiib endoleak) were identified in the distal portion of the bifurcated device.The patient is reportedly in stable condition.As of date, there have been no additional patient sequelae reported.Additional information: during the clinical assessment, the clinical personnel determined that there was evidence to reasonably suggest a rupture and death occurred 10 days after the open repair that was not included in the event as 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.At the completion of the clinical assessment, the type ii endoleak, type iiib endoleak, type ia endoleak, open repair and sac growth events are unconfirmed due to a lack of relevant medical imaging or records.The current patient condition of doing well is refuted, the patient passed away on the tenth (10) hospitalization day.During the investigation, the clinical assessment determined that there was evidence to reasonably suggest a rupture and death occurred that was not included in the event as reported.Device, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms identified were acute renal failure, acute respiratory failure, cardiac arrest and cpr.The patient passed away on hospital day 10 following a cardiac arrest.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 on (b)(6) 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.Corrections: h6: device remove code 1506; h6: result remove code 3233; h6: conclusion remove code 11.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9775184
• MDR Text Key: 190300074
• Report Number: 2031527-2020-00071
• 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: 02/03/2020

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: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1059707-013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX LIMB STENT GRAFT 1039959-025.; AFX SUPRARENAL AORTIC EXTENSION 1054960-009.
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 79 YR