MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/16/2021
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 implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately one (1) year post initial procedure, unknown reintervention was performed to treat a type ii endoleak (non-device related).Approximately two (2) years post-reintervention computerized tomography angiogram identified that the aneurysm sac continues to expand and that there is a possible type 3b endoleak in the distal body of the afx2 bifurcated stent graft.There is a new small type ii endoleak as well.Additional angiogram is planned with a possible re-line of the device; however, it is not yet scheduled.The patient is reported to be stable.
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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being.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.B1: outcomes attributed to ae - updated b5: describe event or problem ¿ updated g3: awareness date - updated h6: health effect - impact codes - remove code 4614 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 implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately one (1) year post initial procedure, unknown reintervention was performed to treat a type ii endoleak (non-device related).Approximately two (2) years post-reintervention computerized tomography angiogram identified that the aneurysm sac continues to expand and that there is a possible type 3b endoleak in the distal body of the afx2 bifurcated stent graft.There is a new small type ii endoleak as well.Additional angiogram is planned with a possible re-line of the device; however, it is not yet scheduled.The patient is reported to be stable.Subsequent to the initial report, additional information was provided reporting that reintervention was completed with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.An angiogram was not performed due to renal function; however, based on the ct (computed tomography) scan it is assumed that it was a type 3b endoleak.The type 3b endoleak was successfully sealed post re-line.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: 12870845
• Report Number: 2031527-2021-00474
• Device Sequence Number: 6119904
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)180828
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: 08/28/2018
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 1732872-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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 VELA SUPRARENAL (LN 1801885-002).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female