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

Model Number	I16-16/C88 SA
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, a clinical evaluation identified a malposition of the right iliac limb placed which covered the right internal iliac artery.Additionally the physician placed an additional limb extension to keep the right iliac patent.The most likely cause of the difficulty deploying the right iliac limb extension could not be determined.The malposition of the limb extension inadvertently covered the right internal iliac artery (cautionary use condition-unable to preserve one internal iliac artery) and a bridge limb extension was placed.Additionally, the limb extension was deployed either between the main body stent and fabric or outside the main body in the aneurysm sac, due to the limited information available the clinical assessment is unable to determine exact location.Clinical harms associated with this event included: occlusion (right internal iliac artery) and prolonged procedure.The event devices remain implanted in the patient and were not available for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
A patient was initially implanted with afx devices to repair an abdominal aortic aneurysm and a common iliac artery aneurysm.During the implant procedure the physician had difficulty with deploying the limb extension.It was reported there was resistance when retracting the delivery system of the device.Additional troubleshooting was completed and at the conclusion of the deployment of the limb the landing zone was missed.The limb extension landed lower then intended causing the internal iliac artery to be covered.The physician had to implant additional limb extensions to resolve the issue.The initial procedure was completed and the patient is reported to be in stable condition.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the difficulty to deploy the right iliac limb extension was found to be unknown/undetermined.The malpositioned limb extension inadvertently covered the right internal iliac artery and a bridge limb extension was placed to resolve this.Additionally, a limb extension was placed between the main body stent and fabric or outside the main in the sac.The exactly location was unable to be determined.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7217096
• Report Number: 2031527-2018-00052
• Device Sequence Number: 16176982
• Product Code: MIH
• UDI-Device Identifier: 00818009011404
• UDI-Public: (01)00818009011404(17)190228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: I16-16/C88 SA
• Device Lot Number: 1299324-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR