MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	07/12/2023
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 treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2019 with the implant of afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix extender.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.On (b)(6) 2023, endologix was notified that the recent computed tomography scan identified aneurysm growth of 5cm that appears stable and a possible type iiib endoleak near the bifurcation of the afx2.Reintervention is scheduled for (b)(6) 2023.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2019 with the implant of afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix extender.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.On (b)(6) 2023, routine follow-up computed tomography scan identified aneurysm growth of 5cm that appears stable and a possible type iiib endoleak near the bifurcation of the afx2.Reintervention is scheduled for 08/04/2023.The patient is in stable condition.After the initial report, reintervention was completed on (b)(6) 2023, with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal and two (2) ovation ix extenders.The type iiib endoleak was successfully sealed.Patient was stable post-procedure.
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 iiib endoleak of the distal main body and additional endovascular procedure complaints are confirmed.The aneurysm enlargement complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.It should be noted that the initial procedure was outside of the indications of use (off-label) due to the use of adjunctive device (ovation right common iliac artery limb extension) not being compatible with the afx2 system; however, it is unlikely this contributed to the reported events.Device, or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.The final patient status was reported discharged home on postoperative day 3 in stable condition.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 g4: awareness date - updated h6: health effect - impact code - remove code 4614 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 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: 17452627
• Report Number: 2031527-2023-00199
• Device Sequence Number: 12616575
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)191219
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 12/19/2019
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 2021949005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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 2265696017); OVATION IX EXTENDER (LN FS082918-66)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male