MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA22-60/I13-40

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Occlusion (1984); Pain (1994); Thrombus (2101)

Event Date 05/29/2018

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

The patient was initially implanted with an afx to treat aortic disease.Six years after the original implant the patient had a follow up angiogram for leg pain where it was found the patient had an occlusion of the right limb.The physician performed a secondary procedure two days post angiogram via left side access.The physician found the clot and occlusion were distal of the graft which was resolved via balloon.The operation was successful, and the patient is scheduled to be discharged (b)(6) 2018.Currently, there has been no further reports of negative patient sequelae.

Manufacturer Narrative

Based on the clinical assessment performed the reported right iliac limb occlusion complaint is confirmed.A definitive root cause was unable to be determined for the reported event; however, the event is most likely anatomy related (pre-existing aorto-iliac occlusive disease).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 bilateral iliac stents were present (unknown when stents were placed) occurred that was not included in the event as reported.The bilateral iliac stents were discovered on (b)(6) 2018 during review of the 67-month post implant angiogram study.The device remains implanted in the patient; therefore, device evaluation will not be 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; 2 musick; irvine CA 92618
• MDR Report Key: 7639616
• MDR Text Key: 112423310
• Report Number: 2031527-2018-00558
• 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: 05/30/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2014
• Device Model Number: BA22-60/I13-40
• Device Catalogue Number: F00406
• Device Lot Number: W11-3866R-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR