MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 a diameter of 50mm, with implant of an afx2 bifurcated stent graft and an afx suprarenal aortic extension.Approximately one and a half (1.5) years post initial procedure reintervention was performed to treat the aneurysm enlargement as it had increased to 80mm with suspected type ia endoleak.A gore (non-endologix) 26x3.3 was implanted to treat the type ia endoleak; however, a seal was not achieved.It was then suspected that there was a type iiia or type iiib endoleak.An endurant (non-endologix) 28x82 was deployed with successful seal.Patient status post-reintervention was not provided (reported under mfr# 2031527-2021-00498).Approximately two and a half (2.5) years post-reintervention computerized tomography identified that the aneurysm enlargement increased to 130mm and there was a type iiia endoleak with junction separation between afx2 bifurcated stent graft and afx suprarenal aortic extension).The physician elected to place an endurant (non-endologix) 28x70 to overlap with the distal area of the afx suprarenal aortic extension by 30mm; however, the endurant (non-endologix) stent graft did not land intended and was deployed inside the distal area of the aneurysm, failing to cover the distal area of the afx2 bifurcated stent graft.A second endurant (non-endologix) 28x70 was deployed overlapping the distal area of the first endurant (non-endologix) 28x70 by 30mm.A gore (non-endologix) 32x4.5 was deployed above the bifurcation of the afx2 bifurcated stent graft.The procedure was completed with no endoleaks.Patient status post-reintervention was not provided.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 reported type iiia endoleak (of the aortic components) with complete component separation is confirmed.The reported aneurysm sac growth and secondary endovascular procedure are unconfirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to the concomitant product use of multiple non-endologix stents at initial implant.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported as being stable.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.Corrections: h6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

• 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: 13018372
• Report Number: 2031527-2021-00500
• Device Sequence Number: 14693322
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180803
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 08/03/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1726314-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• 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 SUPRARENAL AORTIC EXTENSION (LN 1673805-023); ENDURANT (NON-ENDOLOGIX); GORE (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male