MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM; LIMB EXTENSION STENT GRAFT

Model Number IS20-25/C65 SA

Device Problems Difficult To Position (1467); Sticking (1597)

Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that during the initial implant of a bifurcated device, a limb extension, and two infrarenal aortic extensions, the nose cone limb extension became stuck.The physician performed a retro-peritoneal cutdown and repositioned the nose cone and sheath allowing the limb extension to be deployed.The physician had lost wire access on the left side earlier on in the case.In addition, due to the amount of tugging and pulling to deploy the limb extension, the patient developed an endoleak.The physician corrected this by implanting a competitor device.It was noted that the patient has a tortuous anatomy and calcification.It was also reported that the procedure lasted 12 hours and the patient required at least 2 units of blood.The patient was reported to be doing fine post procedure.

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Based upon the investigation findings, the reported event is confirmed except for the difficult deployment.There was evidence to support: an inability to retract the delivery catheter of the left iliac extension post a successful deployment.Visual inspection of the delivery catheter confirmed severe kinks and damage in several locations on the outer sheath and the nosecone, likely as a result of the reported tugging and pulling in a tortuous, calcified iliac.The radiopaque tip was found unremarkable.A manufacturing record review was performed, the lot met all release criteria with no issues or deviations that would explain the reported event.The lot usage history showed all units have been consumed and no other units from this lot were involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.Based upon the investigation findings, factors that may have contributed to this event include product use that was incongruent with the ifu due to: the depiction of a juxtarenal aneurysm; an aortic neck diameter of greater than 32 mm; a greater than 90 degree angle of the right iliac artery.Additionally, intentional misuse at implant consisted of: concomitant use of a non endologix right distal extension and right renal artery snorkel.

• Brand Name: AFX SYSTEM
• Type of Device: LIMB EXTENSION STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: elsa ibarbol ; 2 musick; irvine, CA 92618 ; 9495984719
• MDR Report Key: 4792105
• MDR Text Key: 5816836
• Report Number: 2031527-2015-00151
• Device Sequence Number: 1
• Product Code: MIH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

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: 12/05/2017
• Device Model Number: IS20-25/C65 SA
• Device Lot Number: 1253198-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2014
• 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): Required Intervention
• Patient Age: 76 YR