MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160); Clinical Endoleak (4843)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
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 returned device was completed.A visual and where possible functional analysis was performed.The analysis of the returned device shows that the stent was separated into two sections, with the separation occurring at the bottom of the bifurcation.The second section of the afx2 bifurcated stent graft was attached to the afx vela suprarenal.Due to exposure to the decontamination chemical metricide, the stents turned black, making it difficult to identify any tears or holes.Upon close inspection, no tears or holes were detected.It is possible that the location of any tears or holes coincided with the site of the separation in the afx2 bifurcated stent graft.It is important to note that the damage may have occurred during the explant procedure.As a result, the reported type 3b endoleak could not be confirmed.This is moderately consistent with the reported adverse event/incident.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix found the afx2, aneurysm enlargement, type iiib endoleak and dissection (blood vessel) complaints are unconfirmed.The surgical conversion and explant complaints are confirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was not reported.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2021.The left internal iliac artery (iia) was embolized and the afx2 bifurcated stent, afx vela suprarenal and afx limb extension were implanted via left access.Post-deployment, there was a type iiia endoleak from the right common iliac artery (cia) was suspected.The endoleak was resolved intraoperatively by performing balloon touch-up.The patient was to be kept under observation.The pre-discharge computed tomography conducted post procedure (approximately 08/17/2021) identified a suspected type iiib endoleak.As there was no change to the aneurysm diameter at the time, the physician elected to monitor the patient.The follow-up in may 2024, identified aneurysm enlargement of 5mm (54mm to 59mm) compared to the follow-up six months prior.Echocardiography also confirmed that it was most likely type iiib endoleak.Open repair was performed on (b)(6) 2024.Reportedly, the patient had not been taking anticoagulants and there was not much thrombosis within the aneurysm.Proximal aorta vessel dissection occurred due to the adhesions between the vessel and the proximal bare segment of the afx vela suprarenal.The dissection was placed under observation; however, repaired via angioplasty and implant of a viabahn (non-endologix) stent graft.The final patient status was not reported.

• 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: 20232354
• Report Number: 3011063223-2024-00137
• Device Sequence Number: 18271862
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)231117
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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: 11/17/2023
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2403632005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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 LIMB EXTENSION (LN 2279252001); AFX VELA SUPRARENAL (LN 2421483001)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown