MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-120/I20-40

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in the 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 afx with duraply.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 1a and 1b endoleak was identified.A re-intervention was performed.The physician elected to implanted an additional afx suprarenal graft extension and an ovation ix limb extender to treat the leaks.Reportedly, the patient is stable.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 1a and 1b endoleak was identified.A re-intervention was performed.The physician elected to implanted an additional afx suprarenal graft extension and an ovation ix limb extender to treat the leaks.Reportedly, the patient is stable.Additional information received per clinical assessment indicating that movement of the proximal stent also occurred.

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 the reported type ia endoleak and type ib endoleak (of the right common iliac artery (rcia)) are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest that proximal stent movement (of 8mm) occurred.This finding was discovered during an examination of the ct (computed tomography) scan dated (b)(6) 2017.The most likely causation for the reported type ia endoleak and stent movement are user-related due to the proximal neck length measuring 12mm (should be greater than or equal to 15mm per ifu).The most likely causation for the reported type ib endoleak is anatomy-related due to the rcia angulation at the inferior stent margin increasing from 35 degrees to 48 degrees, and also due to the poor stent-to-wall apposition (stemming from the tortuous nature of the artery).No procedure related harms were identified.The final patient status was discharged home on the first post operative day following a secondary endovascular procedure.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.Corrections: b5 describe event or problem.G4 awareness date.H6 device codes (as evaluated); remove 3190.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11628425
• MDR Text Key: 244225442
• Report Number: 2031527-2021-00158
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)200308
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1664192009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL, LOT#1671887006; VELA SUPRARENAL, LOT#1671887006
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR