MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Difficult To Position (1467); Malposition of Device (2616)
Health Effect - Clinical Codes	Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
During the placement of a bifurcated stent for a secondary intervention, the physician was unable to place the bifurcated stent directly on the aortic bifurcation.The placement of the main body stent landed close to the renal arteries and the physician elected to implant renal stents and snorkel the renal arteries as a preventative measure.The secondary intervention was completed and no endoleaks were observed at the conclusion of the procedure.The patient is reported to be doing well and there have been no additional adverse events reported for this patient.The secondary procedure was done to repair a type 3b endoleak were the patient had initially been implanted with a bifurcated stent and a suprarenal aortic extension.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the malposition of the device, renal stenosis, and the use of the renal stents.The most likely cause of the difficult to position and the ultimate malposition of the new main body stent was the intentional user error by using this product to reline an existing stent (cautionary product use condition).Usual procedural steps of deployment were unable to be performed, such as the repositioning of the stent onto the bifurcation (procedure related).There were no anatomy related issues detected.Associated clinical harms associated with this device failure included: renal stenosis; and, unplanned intraoperative renal stenting.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6610160
• Report Number: 2031527-2017-00291
• Device Sequence Number: 10959713
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)170914
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/03/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1590360-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 06/03/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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: Required Intervention
• Patient Age: 83 YR