MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-100/I16-40

Device Problem Off-Label Use (1494)

Patient Problems Aneurysm (1708); Seroma (2069)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

The reported 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 explanted device(s) could not be completed as the device(s) were not returned to endologix.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 incident could not be evaluated.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 incidents.Device iteration is afx2.H3 other text : device discarded by the hospital.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) and a right common iliac aneurysm on (b)(6)2019.An excluder leg (non-endologix) was implanted on the right common iliac artery to the external iliac artery.Then an afx2 bifurcated stent graft and an afx vela suprarenal were implanted.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.At the end of the procedure the aneurysm sac was smaller.At the six months follow-up it grew to an unknown amount.An additional follow-up computerized tomography identified that the that the aneurysm enlargement was approximately 10mm.A type v endoleak was suspected.Reintervention was performed on (b)(6)2023 with the explant of the afx2 bifurcated stent graft and the afx vela suprarenal and the vascular replacement was performed.During the surgery, it was visually confirmed that the aneurysm was not thrombosed.Yellow fluid was observed that was assumed to be seroma.Post-operation, the patient was reported to be stable.

• Brand Name: AFX2
• Type of Device: 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: 17363368
• MDR Text Key: 319482742
• Report Number: 2031527-2023-00181
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0081800901
• UDI-Public: (01)0081800901(17)210326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 2232415003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 2277755008); GORE EXCLUDER LEG (LN UNK)
• Patient Outcome(s): Required Intervention