MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/13/2024
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft, one (1) endurant (non-endologix) iliac limb and two (2) endurant (non-endologix) extensions.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx system per device ifu.A type ii endoleak (non-device-related) from the lumbar artery was noted at initial implant.Approximately six (6) years post initial procedure, the patient presented with aneurysm enlargement (about 5mm).The physician elected to treat the patient by converting to open surgery on (b)(6) 2023.During the re-intervention, the physician slightly moved the afx bifurcated stent graft to check for other endoleaks and blood leaked from multiple holes of the afx device (classified as type iiib endoleaks).As the blood only leaked from these holes if the physician pushed on the graft, the physician chose to not perform additional treatment and concluded the operation.It is believed that the fully expanded endurant stent grafts were sealing the holes.The patient is reportedly discharged.This event was reported under mfr# 2031527-2023-00203.On (b)(6) 2024 the patient was emergently transported to the hospital due to a type iiib endoleak.An afx2 bifurcated stent graft and an afx vela infrarenal were implanted via right access.When balloon touch-up was performed, the afx vela infrarenal migrated proximally; therefore, the physician implanted an additional afx2 bifurcated stent graft and an afx vela suprarenal.The endoleak was resolved and the procedure was completed.
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 that the type iiib endoleak and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The index procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx system per device ifu.It is unclear if this contributed to the reported events.The final patient status was reported as 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 afx with duraply.Corrections: g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• 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: 20182862
• Report Number: 3011063223-2024-00134
• Device Sequence Number: 8931346
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)200201
• 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): Unknown
• 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): 08/14/2024

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: 02/01/2020
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1650464-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC (NON-ENDOLOGIX) ENDURANT AORTIC EXT.; MEDTRONIC (NON-ENDOLOGIX) ENDURANT ILIAC EXT.; MEDTRONIC (NON-ENDOLOGIX) ENDURANT ILIAC LIMB.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male