MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
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, follow-up report will be submitted.Device iteration is an afx with duraply h3 other text : device remains implanted.
Event or Problem Description
The patient initially received treatment for an abdominal aortic aneurysm (aaa) on (b)(6)2015, with the implantation of an afx bifurcated stent graft and an afx vela suprarenal.On (b)(6) 2024, it was reported that a possible type ib endoleak had been identified.On (b)(6) 2024, the patient underwent a re-intervention.During this procedure, the physician implanted three (3) ovation ix iliac limbs, ovation prime fill polymer, and an alto main body.The final patient status remains unknown, as this information was not provided to endologix.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in accordance with endologix's operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good-faith efforts to retrieve the device related to the reported adverse event/incident, as well as to obtain 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 confirmed that the device was properly manufactured and released in accordance with the device master record.The review also confirmed that no manufacturing or processing non-conformities were 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 conducted.An examination of the medical records and/or medical imaging received by endologix confirmed the type ib endoleak of the left common iliac artery, along with the additional endovascular procedure.It was reported that the patient had a left common iliac artery aneurysm at the time of the index procedure.The size of the sac reportedly made it difficult to seat the main body on the bifurcation as it was leaning to the left.It is unclear whether this contributed to the type ib endoleak.It is unclear whether sharp angulation in the left common iliac artery at the time of the index procedure contributed to the type ib endoleak.This finding is consistent with the reported adverse event/incident.The clinical evaluation also revealed reasonable evidence to suggest that an aneurysm enlargement of 14 mm had occurred.Additionally, the assessment identified evidence of a type iiib endoleak in the distal main body, which was not included in the original report.Both the aneurysm enlargement and the type iiib endoleak were discovered during a review of a computed tomography (ct) scan.Procedure-related harms, device-related issues, user-related factors, or anatomical factors contributing to the complaint could not be determined based on the medical records available for review.The final patient status was reported as stable, with the patient discharged home on post-op day one.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 afx with duraply.

• Brand Name: AFX
• 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: 19812414
• Report Number: 3011063223-2024-00108
• Device Sequence Number: 12837756
• Product Code: MIH
• UDI-Device Identifier: 00818009012265
• UDI-Public: (01)00818009012265(17)180807
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 08/07/2018
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1251941-023
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL LOT# 1341528010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male