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

Model Number BA25-80/I13-40

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that during implant of a bifurcated device it resulted in an open conversion to a surgical aorta bifemoral graft placement.Reportedly, it was due to severe calcification and narrowing in the distal aorta and common iliacs where the bifurcated device could not be pulled down past the aortic bifurcation into the common iliac arteries.After many attempts and techniques the device itself started to partially deploy.The physician elected to do an open repair and remove the device and repair with a surgical graft.The patient is 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 retained at user facility.

Manufacturer Narrative

The device was not returned for evaluation therefore not available for analysis.Medical records and computer tomography imaging were provided and reviewed by internal clinical representative with the following impression: there were no medical documentation and suboptimal imaging studies available for this review.Product use was incongruent with the ifu and might have contributed to this complaint due to: the absence of an abdominal aortic aneurysm; and, the left iliac artery diameter of < 10 mm.There were cautionary conditions for product use which might have contributed to this complaint such as: the severe calcifications at the aortic neck, bifurcation and bilateral iliacs.There was evidence to support a difficult and pre-mature deployment of the bifurcated stent.The explant, conversion was confirmed due to the fluoroscopy images demonstrating retractors.The complication of acute renal failure, and a secondary procedure of a tunneled dialysis catheter placement was substantiated.However, the death and cause of death were not substantiated or disclosed.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 that no other units from the same lot 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.Based upon the investigation findings, the root cause appears to be the result of difficult anatomy as reported in the incident and verified by the clinical review.There was no product issue identified in the investigation.

Event Description

It was reported that during implant of a bifurcated device it resulted in an open conversion to a surgical aorta bifemoral graft placement.Reportedly, it was due to severe calcification and narrowing in the distal aorta and common iliacs where the bifurcated device could not be pulled down past the aortic bifurcation into the common iliac arteries.After many attempts and techniques the device itself started to partially deploy.The physician elected to do an open repair and remove the device and repair with a surgical graft.The patient is in stable condition.However, approximately five days post implant the patient expired due to multiple issues.

• Brand Name: AFX SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• 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: 4038497
• MDR Text Key: 4861248
• Report Number: 2031527-2014-00253
• 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,Followup
• Report Date: 07/27/2014

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1136124-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/08/2014; 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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