MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2021, during which an afx2 bifurcated stent graft and two afx vela suprarenals were implanted.On march 26, 2024, the physician reported suspicion of an endoleak type iiib, where the distal end of the cuff touches the main body.Discussions regarding plans for re-intervention are underway.The patient's condition is reported as stable with no complications.
Additional 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 : device remains implanted.
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2021, during which an afx2 bifurcated stent graft and two afx vela suprarenals were implanted.On march 26, 2024, the physician reported suspicion of an endoleak type iiib, where the distal end of the cuff touches the main body.Discussions regarding plans for re-intervention are underway.The patient's condition is reported as stable with no complications.Additional information: on (b)(6) 2024, the patient underwent a re-intervention, during which the physician opted to implant an afx2 bifurcated stent graft.The final status of the patient remains undisclosed, with endologix not having received any updates on the matter.
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 was 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 suspected type iiib endoleak is unconfirmed.The type ii endoleak (anatomy-related) and additional endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a previous endovascular procedure (coiling of the lumbar arteries) also occurred.The lumbar coiling was discovered during the review of the angiogram dated 06/20/2022.The coiling in the sac created an artifact, making it difficult to assess for type iiib endoleak.Procedure-related harms of this complaint could not be determined with the medical records available for review.The final patient status was reported as stable.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.

• 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: 19086990
• Report Number: 3011063223-2024-00056
• Device Sequence Number: 15228835
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)230729
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/26/2024

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: 07/29/2023
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2372274-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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 VELA SUPRARENAL 2359648002; AFX VELA SUPRARENAL 2359648006
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male