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

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/23/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately five (5) months post initial procedure, a graft occlusion was identified.It was reported by the physician that the occlusion was most likely due to the patient's drug use.An intervention was completed.The physician elected to performed an ax-bi-fem bypass with non endologix devices.The patient was reported as doing well post intervention.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, the right iliac graft occlusion resulting in an axillary to femoral bypass procedure is confirmed.The event is most likely user related due to the patient having pre-existing aorto-iliac occlusive disease (critical stenosis at the bifurcation), the distal circulation to the bilateral lower extremities were severely compromised prior to the evar procedure, the patient required thromboembolectomies and fasciotomies during the procedure and continued use of methamphetamine and nicotine.There were no procedure related harms identified attributed to the device.The patient was discharged on the sixth hospitalization day home and stable following right leg bypass surgery and right internal and external iliac thromboembolectomies.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections: g1,2: contact office- contact has been updated h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9107666
• Report Number: 2031527-2019-00435
• Device Sequence Number: 2346896
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)200117
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 01/17/2020
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 2037351-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 06/15/2020
• 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: 46 YR