MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I16-30

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504); Separation Problem (4043)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the 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 Description

The patient was initially implanted with an afx2 bifurcated stent graft, an afx vela suprarenal aortic extension, an afx vela infrarenal aortic extension and two (2) gore (non-endologix) iliac limbs to treat an abdominal aortic aneurysm (aaa).An express sd (non-endologix) stent was implanted as a "chimney" stent in the left renal artery due to the short aortic neck and the right renal artery was intentionally occluded.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.Approximately one (1) year post initial procedure, the patient required a contrast computed tomography (ct) due to a fall which resulted in swelling of the buttocks which revealed that in addition to internal hemorrhage of the buttocks, contrast flow into the aneurysm was confirmed.There was also disseminated intravascular coagulation (dic) confirmed and a type 3b endoleak was suspected.Additionally, a junction separation between the afx2 bifurcated stent graft and the proximal vela suprarenal aortic extension was observed.The source of the endoleak could not be determined as the endoleak was not visible on angiogram.The physician elected to perform an emergency endovascular procedure on (b)(6) 2023 as a type 3b endoleak was suspected and relined the previously implanted stent grafts with an additional afx2 bifurcated stent graft, two (2) infrarenal aortic extensions and one (1) suprarenal aortic extension.Balloon touch-up was performed but flow into the aneurysm was still observed on echocardiography.Gore (non-endologix) iliac limbs were implanted one on each side and balloon touch-up was performed once again.Flow into the aneurysm was still observed; however, the physician elected to not further intervene.T he physician treated the internal hemorrhage of the buttocks and finished the procedure.Upon post procedure follow up evaluation it was confirmed original endoleak was type 3b and currently there was no longer an endoleak and the patient was discharged.

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 because it remains implanted.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 adverse event/incident could not be evaluated.The final patient status was reported as discharged after intervention.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.Corrections: h6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• 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: 18276287
• MDR Text Key: 329850414
• Report Number: 3011063223-2023-00039
• Device Sequence Number: 1
• Product Code: MIH
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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 Model Number: BEA28-90/I16-30
• Device Lot Number: 2554246006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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: AFX VELA INFRARENAL, LOT # 2528553003; AFX VELA SUPRARENAL, LOT # 2552171002; EXPRESS SD (NON-ENDOLOGIX); GORE STENT GRAFT (NON-ENDOLOGIX); GORE STENT GRAFT (NON-ENDOLOGIX)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male