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

Model Number	BEA22-70/L16-30
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	09/10/2019
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
During the initial implantation of a bifurcated stent graft (main body) to treat a dissection associated with an aorta enlargement, an intraoperative type 1a endoleak was observed.This procedure is outside the indications of use (off- label).It was reported that the aorta was 75 mm in length and that the 70 mm main body landed lower than expected.A proximal extension was not suitable due to the patients anatomy.The physician preformed ballooning but a small type 1a endoleak was still present.The physicians elected to complete the procedure and monitor the patient.The patient was reported as doing fine.
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 type 1a endoleak and malposition of the main body stent was unable to be confirmed due to the lack of relevant medical records and/or imaging available for review.However, the pre-existing aortic dissection was confirmed and stenosis in the area of the aortic dissection was also identified.As the pre-existing aortic dissection with absence of an abdominal aortic aneurysm is an off-label condition, this event is most likely user related.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.
Event or Problem Description
Additional information: during the investigation of this event, stenosis in the area of the aortic dissection was also identified.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9168741
• Report Number: 2031527-2019-00448
• Device Sequence Number: 2811226
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)200629
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 06/29/2020
• Device Model Number: BEA22-70/L16-30
• Device Lot Number: 2266496-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 67 YR