MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I13-40

Device Problem Off-Label Use (1494)

Patient Problem Vascular Dissection (3160)

Event Date 02/13/2024

Event Type  Injury  

Event Description

The patient was being implanted with an afx2 bifurcated stent graft for treatment of aortic occlusive disease with no abdominal aortic aneurysm (aaa).The post operative angiogram from placing the afx2 device showed a filling defect and the physician decided to cuff up to renal arteries with an ovation ix extender due to a dissection in the aorta rather than leave it.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 and lack of an aaa.It was noted that the patient already had the dissection; however, the physician was not planning on extending to the renal arteries.The dissection in the aorta was successfully resolved.

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.

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 was completed.An examination of medical records and/or medical imaging received by endologix shows that the aortic dissection is unconfirmed.This was an off-label case and likely contributed to the reported event but could not conclusively be determined.This is moderately consistent with the reported adverse event/incident.The patient was being treated for aortoiliac occlusive disease with thickened calcium.There was no abdominal aortic aneurysm.The right common iliac artery distal diameter was 4.3mm and the left common iliac artery distal diameter was 4.1mm (should be 10-23mm).The proximal aortic neck diameter was 9.2mm (should be 18-32mm).The initial procedure is off label due to concomitant product usage (ovation extension proximally) not compatible with the afx system per device ifu.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.The final patient status was reported as being monitored.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: g3: awareness date has been updated.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: 18818599
• MDR Text Key: 336734327
• Report Number: 3011063223-2024-00030
• Device Sequence Number: 1
• Product Code: MIH
• 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,Followup
• Report Date: 02/13/2024

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: BEA22-60/I13-40
• Device Lot Number: 2744703002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/06/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2024
• 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 INTRODUCER SYSTEM II, LOT # 2732253070; OVATION IX EXTENDER, LOT # FS102022-13
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female