MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504)

Patient Problem Aneurysm (1708)

Event Date 01/10/2024

Event Type  Injury  

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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 3a endoleak, type 3b endoleak aneurysm enlargement and explant are unconfirmed due to a lack of the medical information surrounding the event.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Unable to identify the contributing factors due to a lack of the medical information.This is an off label - concomitant use with products outside the ifu.The final patient status was reported being stable post the explant.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.H3 other text : device was not returned to endologix.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, two gore (non-endologix) and two endurant (non-endologix) stent grafts.Both the left and right internal iliac arteries were occluded by coils prior to the endovascular aortic repair (evar) procedure.A gore leg was implanted in the right iliac and gore iliac extender was implanted in the left iliac.Then an endurant aortic extender and an iliac extension were implanted below the renal artery.Next, the afx2 bifurcated stent graft was implanted.During deployment of the afx2, the endurant iliac extension migrated towards the aneurysm.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.It was reported that in (b)(6) 2022 (exact date is unknown) coil occlusion was performed for type 2 (non-device related) endoleak.Additionally, in (b)(6) 2022 (exact date is unknown), an indeterminate type endoleak was observed on follow-up computed tomography (ct) images.This event was previously reported under mdr # 3011063223 -2024-00048.It was also reported that in (b)(6) 2023 (exact date is unknown), aneurysm enlargement was observed on follow-up computed tomography (ct) images.This event was previously reported under mdr # 3011063223 -2024-00049.On (b)(6) 2024 the physician elected to perform an open surgical repair and during the open surgical repair noted a type 3a endoleak at the junction between the endurant stent graft and the afx2 overlap.Additionally, a type 3b endoleak was confirmed from the afx2 around the origin of the limb close to sutures.The afx2 stent graft was explanted, but it was not provided to endologix for the investigation.The explanted stent graft was replaced with artificial vessels and the procedure was completed.The patient's post-operative condition was reported as stable and was discharged.

• 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: 19030444
• MDR Text Key: 339207675
• Report Number: 3011063223-2024-00050
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)231130
• 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: 03/12/2024

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 Expiration Date: 11/03/2023
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 2406836001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: COILS (NON-ENDOLOGIX).; ENDURANT (NON-ENDOLOGIX) AORTIC EXTENSION.; ENDURANT (NON-ENDOLOGIX) ILIAC EXTENDER.; GORE (NON-ENDOLOGIX) ILIAC EXTENDER.; GORE (NON-ENDOLOGIX) LEG.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male