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

Model Number	BA25-90/I16-30
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2017, an evar was performed for a patient with abdominal aortic aneurysm.A pig catheter was inserted from the right upper arm and advanced to the descending aorta.A non - endologix stent stent graft was implanted on the left limb first.Through the right femoral approach, an endologix bifurcated stent graft was inserted next.During the bifurcated stent graft deployment, there was a difficulty on retracting the control cord and it was unable to be completely retracted.The non - endologix stent from the proximal edge seemed not be deployed as a result.When the tension was applied again on the control cord, the tip of endologix bifurcated stent graft bent (buckled).The bifurcated stent graft was fully deployed at that time, however the tip of bifurcated stent graft still looked to be contacted to the aorta wall.A non - endologix ipsilateral limb was deployed and then a endologix proximal extension was implanted right away in order to cover endologix bifurcated stent graft deformation.Then a non - endologix contralateral limb was then deployed.An angiogram showed no endoleaks.The procedure was completed.There have been no patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The evaluation results are inconclusive.The following component have been evaluated by direct observation of physical device: one afx bifurcated delivery system without implant (ba25-90/i16-30).The evaluation result for the ba25-90/i16-30 did not support the reported the event of deployment difficulty, buckled implant.The delivery system exhibits some damaged.Due to the method of packaging for return, it is not possible to determine the cause or timing of observed damage.No functional defects were observed during evaluation.The implant was not returned for evaluation.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of a non-endologix left limb stent placed prior to endologix bifurcated stent, difficulty in retraction of control cord, buckling of the main body and possible imbedded strut of main body in aorta the most likely cause of the difficulty to deploy was unknown, however the superior stent margin of the left iliac stent was deployed within the bifurcation area before the main body stent, which might have complicated the removal of the outer sheath.The buckling of the superior stent margin of the main body was caused by the difficult retraction in the control cord, and may have resulted in a strut embedment in the right lateral wall of the aorta.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7167571
• Report Number: 2031527-2018-00019
• Device Sequence Number: 16578484
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)200524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/13/2017

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: 05/24/2020
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1689691-009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX CUFF EXTENSION, LOT # 1709221-004; FOUR (4), NON-ENDOLOGIX STENTS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR