MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-110/I20-30

Device Problem Lack of Effect (4065)

Event Date 04/01/2024

Event Type  Injury  

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2023, with the implantation of an afx2 bifurcated stent graft, an afx vela infrarenal, and an afx vela suprarenal.It was reported on (b)(6) 2024, that the patient underwent a re-intervention for an endoleak type ib.The physician implanted an additional afx2 bifurcated stent graft and an ovation ix extender.The final patient status was reported as doing well with no presence of an endoleak.

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.H3 other text : devices remain implanted.

• 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: 19169591
• MDR Text Key: 340897388
• Report Number: 3011063223-2024-00060
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014818
• UDI-Public: (01)00818009014818(17)240908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: BEA25-110/I20-30
• Device Lot Number: 2505375-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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 INFRARENAL 2361261007; AFX VELA SUPRARENAL 2578207020
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male