MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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 treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and afx vela infrarenal.Approximately one (1) year post initial procedure, the patient presented with an enlarged aneurysm (unknown diameter) and a suspect endoleak (at an indeterminate origin).The patient is currently being monitored.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the indeterminate endoleak was identified as a type iiia endoleak of the aortic components.The sac growth of 6.4mm is confirmed.This moderately consistent with the reported adverse event/incident.The most likely causation for type iiia endoleak and sac growth is anatomy related.Procedure related harms for this adverse event/incident could not be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The type iiia endoleak was in the angulation of the aorta where the initial overlap of the afx2 bifurcated stent graft and proximal extension was (anatomy related).The neck was off label as the proximal neck was 17mm and should be greater than or equal to 18-32mm.The iliac diameters were off label at 9.7 and 9.5mm and should be between 10-23mm.The access diameters were off label at 3.2mm and should be greater than or equal to 6.5mm.The final patient status was reported as being discharged.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx2.B2: outcomes attributed to ae - updated.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove 3190.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and afx vela infrarenal.Approximately one (1) year post initial procedure, the patient presented with an enlarged aneurysm (unknown diameter) and a suspect endoleak (at an indeterminate origin).The patient is currently being monitored.Subsequent to the initial report, additional information was provided reporting that reintervention was completed with implant of an afx vela suprarenal to treat the type ia endoleak.Post-deployment during withdrawal of when the delivery system the tip of the delivery system became stuck on the endoskeleton and the afx vela suprarenal migrated slightly distal; however, more than one stent segment was still above the neck.An afx vela infrarenal was deployed with its proximal end aligned with the distal end of the junction between the afx2 bifurcated stent graft and the afx vela infrarenal which were both implanted in the initial evar procedure successfully treating the type iiia endoleak.Reportedly, the patient was discharged.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 12694345
• Report Number: 2031527-2021-00452
• Device Sequence Number: 12008504
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)191030
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 10/30/2020
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 2006357001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL 1783898-006.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female