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

Model Number BA28-80/I16-40

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); No Information (3190)

Event Date 02/01/2018

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

Patient was presented with a migrated graft and possible graft separation.It was noted that more research and discussion will be addressed and what anatomical changes have taken place on the patient by the physician.If there is a definitive endoleak (and what type), a treatment plan will be presented.No further information was provided.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm the patient's endoleak type 1a, stent migration and the partial crown separation of the cuff (with an endoleak type 3b-will be reported separately).In addition, clinical also found stent dilation on the main body stent, sac growth, and a fractured crown of the initial suprarenal cuff.Due to the lack of medical imaging, clinical was not able to confirm the open repair (explant) on the patient that was performed on (b)(6) 2018.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the stent migration, which likely resulted in the proximal loss of seal, and compromised stent graft integrity of the cuff (stretched and breached) and the main body stent (stretched) was the hostile aortic neck anatomy.The progressive compromised fabric likely resulted in the partial crown separation and strut fracture of the cuff.It was reported that the patient was doing well post explant.There have been no further reports of negative patient sequelae.The explanted device was returned for evaluation.The explanted device did not exhibit any signs of defect or damage other than that typical of an explant procedure.The two device had sufficient overlap (40 mm) and were still joined as one unit at time of evaluation.It was concluded that the evaluation was inconclusive.A review of the manufacturing lot confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.

Event Description

Patient was presented with a migrated graft and possible graft separation.It was noted that more research and discussion will be addressed and what anatomical changes have taken place on the patient by the physician.If there is a definitive endoleak (and what type), a treatment plan will be presented.On (b)(6) 2018, physician elected to do a conversion/explant procedure.The graft was removed and a surgical graft was sewn in.The patient seemed to tolerate surgery well.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7313656
• MDR Text Key: 101509249
• Report Number: 2031527-2018-00147
• 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: 02/05/2018

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: 11/30/2012
• Device Model Number: BA28-80/I16-40
• Device Catalogue Number: F00426
• Device Lot Number: W11-6053-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION, LOT W11-3991R-019; SUPRARENAL AORTIC EXTENSION, LOT W11-3991R-019
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR