MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I13-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

Patient Problems Cardiopulmonary Arrest (1765); Failure of Implant (1924); Shock (2072); Rupture (2208)

Event Date 10/09/2017

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

Patient was initially implanted with an afx bifurcated and suprarenal graft.The patient declined additional follow up after the initial implant procedure.Approximately 4 years post initial implant, the patient presented at the hospital with aneurysm sac growth.The physician elected to implant the device; upon explant it was confirmed that there was an endoleak type iiib.There has been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type iiib.The reported explanted graft and open repair was refuted.Additionally there was evidence to reasonably support a prolonged hospitalization that included a ruptured graft, an intra-operative cardiac arrest with shock, acute respiratory failure, acute kidney injury, thrombocytopenia and atrial fibrillation, and stent cage dilation of the main body.The most likely cause of the compromised stent graft integrity of the main body stent (stretched and breached) was the use of strata material.The reported medical noncompliance contributed to the rupture event (cautionary product use).Procedure related harms include acute respiratory failure, acute kidney injury and atrial fibrillation.Per the patient's family request, the patient was transferred to another facility on the twelfth post-operative day still on respiratory support.The final patient disposition is unknown.There have been no further reports of negative patient sequelae.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 (b)(6) 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.Root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to <0.2%.Device was not returned, therefore, sample evaluation was not completed.The review of manufacturing lot 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.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7007029
• MDR Text Key: 91249546
• Report Number: 2031527-2017-00586
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

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: Physician
• Device Expiration Date: 03/30/2016
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1129430-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL-LOT: 1050593-038
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR