MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; BIFURCATED STENT GRAFT

Model Number BIFURCATED STENT GRAFT

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Failure of Implant (1924); Ischemia (1942); Renal Failure (2041); Sepsis (2067); Blood Loss (2597)

Event Date 09/24/2019

Event Type  Death  

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted."device iteration is afx2".

Event Description

It was reported that during initial procedure to treat an abdominal aortic aneurysm (aaa) the contra limb of the bifurcated stent graft became stuck on the struts of a balloon expandable stent (non-endologix) that was previously implanted bilaterally in both common iliac arteries.The physician was unable to resolve this issue.Therefore, the physician performed an open procedure and explanted the graft.This case is outside the indications of use (off -label).The patient was reported as doing well.

Event Description

It was reported that during initial procedure to treat an abdominal aortic aneurysm (aaa) the contra limb of the bifurcated stent graft became stuck on the struts of the previously implanted balloon expandable stents (non-endologix) that were implanted bilaterally in both common iliac arteries.Therefore, the physician performed open procedure and explanted the graft.This case is outside the indications of use (off -label).The patient was reported as doing well.Additional information: the clinical assessment identified the following procedure related harms during a review of the medical records: abnormal blood loss, ischemic colon, sepsis, two (2) additional surgical procedures, acute kidney failure, prolonged hospitalization, cardiopulmonary resuscitation (cpr) and patient death.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the event of the conversion to open repair after a failed endovascular repair procedure.The event is most likely user related.The clinical assessment identified the following procedure related harms: abnormal blood loss, ischemic colon, sepsis, two (2) additional surgical procedures, acute kidney failure, prolonged hospitalization, cardiopulmonary resuscitation (cpr) and death.The patient death on (b)(6) 2019 was determined to be procedure related due to the pre-existing iliac stents (off label concomitant product use), causing the contra limb to become lodged in the right common iliac artery, necessitating the open repair procedure and subsequent negative patient sequelae.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 afx2.Corrections: b2: outcomes attributed to adverse events has been updated.E1: initial reporter, name and address has been updated.H6: device code: remove code 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9236145
• MDR Text Key: 165655860
• Report Number: 2031527-2019-00475
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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: 12/19/2019
• Device Model Number: BIFURCATED STENT GRAFT
• Device Lot Number: 2021894014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 53 YR