MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
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, clinical was able to find substantial evidence to support the following reported event of a 1a endoleak with sac growth.Clinical also found the following additional findings of a type 2 endoleak, a possible av fistula, an inferior vena cava and false aortic lumen fistula.The 1a endoleak was most likely user related due to the off-label aorta and off-label concomitant use of a non endologix device.The type 2 endoleak (non- device failure), possible av fistula, an inferior vena cava and false aortic lumen fistula are most likely anatomy related.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft within pre-existing non- endologix (cook tube) cuff that was leaking (1a endoleak).Approximately two (2) months post initial procedure, another type 1a endoleak with sac growth was identified.A secondary procedure was completed.The physician elected to implant a suprarenal stent graft extension (cuff) to resolve this endoleak.The procedure was reported to be successful.As of the date of this report, there have been no additional patient sequelae reported.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8259509
• Report Number: 2031527-2019-00040
• Device Sequence Number: 19409896
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)190619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 06/19/2019
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1950117-004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/17/2019
• 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: Required Intervention
• Patient Age: 70 YR