MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2019, with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix iliac limb.This initial procedure is outside of the indications of use due to the use of adjunctive devices not compatible with the afx2 system.On (b)(6) 2024, it was reported that the patient had an endoleak type ib, an aneurysm enlargement, and a possible endoleak type 3b.The patient is scheduled for a re-intervention on (b)(6) 2024.
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 afx2 h3 other text : device remains implanted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.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 aneurysm enlargement of 9.4 mm, type ib endoleak of the left common iliac artery, the type iiib endoleak of the distal main body, and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The initial procedure is off label due to concomitant product usage (ovation limb in the right common iliac artery) not being compatible with the afx2 system per device ifu.It is unclear if this contributed to the reported type iiib endoleak.The final patient status remains unknown.The final patient status was not made available to endologix.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: b2: outcomes attributed to adverse events has been updated b5: describe event or problem has been updated.G3: date of received by manufacturer.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2019, with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix iliac limb.This initial procedure is outside of the indications of use due to the use of adjunctive devices not compatible with the afx2 system.On (b)(6) 2024, it was reported that the patient had an endoleak type ib, an aneurysm enlargement, and a possible endoleak type 3b.The patient is scheduled for a re-intervention on (b)(6) 2024.Additional information: on (b)(6) 2024, the patient underwent a re-intervention during which the physician chose to implant an afx2 bifurcated stent graft and an afx vela suprarenal device.The final status of the patient remains unknown, as this information was not provided to endologix.

• 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: 19225716
• Report Number: 3011063223-2024-00066
• Device Sequence Number: 12810563
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)200205
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 02/05/2020
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 2054000-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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 (B)(6); OVATION IX ILIAC LIMB (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male