MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA25-100/I20-40

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Death (1802); Occlusion (1984); Renal Failure (2041); Heart Failure (2206); Rupture (2208)

Event Date 04/22/2019

Event Type  Death  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

During an re-intervention for non-endologix devices, an afx2 bifurcated stent graft was implanted to treat an occlusion of the right common iliac limb.This procedure is outside the indications of use (off- label).The patient was reported to have renal failure, serum creatinine of 7.6 after dialysis, stenosis, and a highly calcified left common iliac internal iliac.The physician elected to create an aorto-uni-iliac (aui) using the bifurcated stent graft.After the bifurcated stent graft was implanted, the nose cone would not retract distally for removal and several attempts were made to remove the device.The iliac subsequently tore in half while removing the delivery sheath.An emergency laparotomy was performed with a hemo-shield dacron (non-endologix) graft sewn in place and the physician was able to control the bleeding.However, the patient then went into cardiac arrest and expired during the procedure.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: total right common iliac artery (rcia) occlusion (pre-operative), difficulty in retracting the nosecone, left common iliac artery (lcia) rupture, subsequent transition to an open repair, and death.These events are most likely user-related due to the off-label use with a noncomitant product (left common iliac stent) and utilizing the bifurcated stent as an aorto-uni-iliac (aui) device by ligating the limb with silk ties.The inability to remove the nosecone and resultant iliac rupture was related to the pre-existing non-endologix stent.The cause of the surgical conversion and death was the left iliac rupture.The procedure-related harms identified were the rupture, surgical conversion, abnormal blood loss, cardiopulmonary resuscitation (cpr), intraoperative open repair, and death.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is afx2.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8579356
• MDR Text Key: 144013916
• Report Number: 2031527-2019-00219
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)190913
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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: 09/13/2019
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1986820-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 78 YR