MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 an afx2 bifurcated stent graft and a suprarenal extension to treat an abdominal aortic aneurysm.Approximately 4 years post initial procedure the patient was identified with a type 1b endoleak during a routine follow up.The patient was reported as stable and the physician is planning a re-intervention.
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 the device 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 type ib endoleak is unconfirmed and the additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.Though the type ib endoleak could not be confirmed, the right common iliac was off label measuring at 2.8cm and should be 10-23mm.Additionally, there was the absence of an abdominal aortic aneurysm which is off label.A definitive root cause for the reported adverse event/incident could not be determined; however, the off-label use could have been a contributing factor.Device and procedure related harms for this event could not be determined.The final patient status was reported as 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.H6: health effect - impact code ¿ remove 4614.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a suprarenal extension to treat an abdominal aortic aneurysm.Approximately 4 years post initial procedure the patient was identified with a type 1b endoleak during a routine follow up.The patient was reported as stable and the physician is planning a re-intervention.After the initial report, additional information was received, reporting that reintervention was completed with the implant of an ovation ix extender.The type 1b endoleak was successfully sealed, and there were no adverse complications.The final patient status was reported to be stable.

• 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: 15297899
• Report Number: 2031527-2022-00212
• Device Sequence Number: 5839048
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)181013
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 10/13/2018
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 1749754-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL SERIAL# (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male