MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-55
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/06/2019
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 and infrarenal stent to treat an abdominal aortic aneurysm.Approximately, 5 years post-operative a ct identified a type iiib endoleak and physician elected to reline with a bifurcated stent graft and 2 infrarenal stents.This was previously reported under 2031527-2017-00494.Now, approximately 1.5 years post secondary procedure, the sac growth was identified.The physician elected to undergo an open exploration.No blood or leaks were visible but a thin yellow fluid was evacuated (no smell and c & s was negative).Ultimately a portion of the aorta was resected and rest closed back down around the intact grafts.The patient was reported as doing extremely well.
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 reported sac growth and the open repair (stent remained in place, surgeon removed part of the sac only) were confirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the available medical / images to review.The final patient status was reported to be doing well.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: 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; 2 musick; irvine CA 92618
• MDR Report Key: 9263856
• Report Number: 2031527-2019-00488
• Device Sequence Number: 3731320
• Product Code: MIH
• UDI-Device Identifier: 00818009014924
• UDI-Public: (01)00818009014924(17)180303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 03/03/2018
• Device Model Number: BEA25-80/I16-55
• Device Lot Number: 1663142005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 06/16/2020
• 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: BIFURCATED STENT GRAFT, LOT#W11-5522-004; INFRARENAL AORTIC EXTENSION, LOT# 1030607-015; VELA INFRARENAL, LOT#1670889004; VELA INFRARENAL, LOT#1707888005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR