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

Model Number BA25-90/I16-30, BA28-100/I16-40

Device Problems Leak/Splash (1354); Premature Activation (1484)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was reported that there were two issues during this case.The first bifurcated device was implanted, and an endoleak was identified.Reportedly, a post angio was done after implant and an endoleak was identified on the left side of the bifurcated device at the junction of the iliac and main body.The physician then treated the endoleak with another bifurcated device to seal, and it prematurely deployed.Therefore the physician chose to successfully remove the device after premature deployment of the proximal 1-2 segments of the graft.Thereafter a third bifurcated device, and two suprarenal aortic extensions were implanted successfully, and eliminated the endoleak.Patient tolerated the procedure well.

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 manufacture date - 04/15/2014.Additional date added for (b)(4).Device remains implanted in patient.

Manufacturer Narrative

Based upon the investigation findings, the reported event is inconclusive.There was no medical documentation and suboptimal imaging studies available for this review.Product use was incongruent with the ifu and might have contributed to this event due to: the greater than 60 neck angulation.Stent placement within an existing stent was a cautionary product use, and might have contributed to the premature deployment of this stent.A manufacturing record review was performed, the lot met all release criteria with no related issues or deviations that would explain the reported event.The lot usage history showed all units were consumed and no other units were involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.

• Brand Name: AFX SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: gail hapner ; 2 musick; irvine, CA 92618 ; 9495984611
• MDR Report Key: 4157620
• MDR Text Key: 15359539
• Report Number: 2031527-2014-00289
• 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: 09/09/2014

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: 08/07/2014
• Device Model Number: BA25-90/I16-30, BA28-100/I16-40
• Device Lot Number: 1268331-005, 1055281-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• 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: 66 YR