MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM; SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS)

Model Number A28-28/C75-O20 V

Device Problem Sticking (1597)

Patient Problems Calcium Deposits/Calcification (1758); Excessive Tear Production (2235)

Event Date 03/17/2014

Event Type  Injury  

Event Description

It was reported that during implantation of a bifurcated device and a suprarenal aortic extension, tearing of the left iliac artery occurred.Reportedly, the patient's left iliac artery was severely calcified, and during aortic extension delivery system retraction, resistance was felt.Angiography revealed the system became stuck in the left iliac, due to the hard calcium in the vessel.The physician manipulated the delivery system without success, and ultimately applied additional force, which released the delivery system from the vessel.Repeat angiography revealed a tear in left iliac artery, and upon inspection of the delivery system, it was observed that approximately a 2 inch segment of the vessel and a pea size of hard calcium, came out with the sheath.The physician performed a fem-by-fem bypass to repair the artery with good result.The patient was reported to be recovering and in stable condition.

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.Device remains implanted in patient.

Manufacturer Narrative

The device remains implanted in the patient and is therefore, not available for analysis.Still images were provided and reviewed by internal medical director.The review indicates the reported event is confirmed.The cause was determined to be related to the extreme calcification of the vessels and associated angulation.No device issue was identified.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 no other units have been involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.Corrected data: contact office.

• Brand Name: AFX SYSTEM
• Type of Device: SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS)
• Manufacturer (Section D): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer Contact: gail hapner ; 11 studebaker; irvine, CA 92618 ; 9495984611
• MDR Report Key: 3698464
• MDR Text Key: 4262124
• Report Number: 2031527-2014-00095
• 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: 03/17/2014

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: Physician
• Device Expiration Date: 01/03/2015
• Device Model Number: A28-28/C75-O20 V
• Device Catalogue Number: 1203991-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2014
• 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: 78 YR