MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Leak/Splash (1354); Stretched (1601)

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

Event Date 05/04/2018

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

Endologix was made aware of a patient with possible sac growth.Patient was found asymptomatic during review of the ct scan by physician on (b)(6) 2018.Physician noted that the aneurysm sac growth went from 5.5cm to 7cm in one year.Patient is scheduled for a secondary procedure (re-intervention) on (b)(6) 2018 with a ovation stent graft.Patient's initial implant date was done on (b)(6) 2014 by dr.(b)(6) at (b)(6).No further information was provided.

Event Description

Subsequent to the initial mdr, it was determined that the afx was relined with ovation on (b)(6) 2018.

Manufacturer Narrative

Based on the information received, clinical assessment confirmed the reported sac growth.The adverse event is most likely device related (use of strata material).Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.Additionally, clinical assessment determined that there was evidence to reasonable suggest a type iiib endoleak of the main body with stent cage dilation of 20% of the main body (stretched and breached) occurred, that was not included in the event as reported.The type iiib endoleak and stent cage dilation were discovered on (b)(6) 2018, during review of the 48 month post implant ct scan.A definitive root cause could not be determined; however, the use of strata material and moderate aortic calcifications likely contributed to this event.The device was not be returned for evaluation.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; 2 musick; irvine CA 92618
• MDR Report Key: 7546886
• MDR Text Key: 109352349
• Report Number: 2031527-2018-00502
• 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
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

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: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: BA28-100/I16-40
• Device Catalogue Number: F00431
• Device Lot Number: 1053309-009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA INFRARENAL, LOT 1230432014
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR