MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I13-40

Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Stenosis (2263)

Event Date 08/05/2022

Event Type  Injury  

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, a follow-up report will be submitted.Device iteration is afx with strata.Device remains implanted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx infrarenal aortic extension.Approximately eight and a half (8.5) years post initial procedure, an undetermined endoleak and mild scattered plaque noted throughout the mid to distal aorta was identified.Flow was noted in the inferior vena cava.The common iliac arteries are visualized with mild stenosis noted in the right 1-19%, and moderate stenosis noted in the left 19-49%.Reintervention has been scheduled.Patient status was not reported.

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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device 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 indeterminate endoleak was determined to be a type iiib of the afx bifurcated stent graft.The distal type iiib endoleak, bilateral common iliac stenosis and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the type iiib endoleak is device related due to the strata material.The most likely causation for the bilateral iliac stenosis is anatomy-related due to the reported significant aortoiliac occlusive disease at the bifurcation with a high-grade stenosis.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The abdominal aortic aneurysm was 49.2mm at index procedure and should be greater than 50mm.No procedure related harms for this complaint were identified.The final patient status was reported to be discharge home on postoperative 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.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.Device iteration is afx with strata.B1: adverse event\product problem - updated.B2: outcomes attributed to ae - updated.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove code 3191.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx infrarenal aortic extension.Approximately eight and a half (8.5) years post initial procedure, an undetermined endoleak and mild scattered plaque noted throughout the mid to distal aorta was identified.Flow was noted in the inferior vena cava.The common iliac arteries are visualized with mild stenosis noted in the right 1-19%, and moderate stenosis noted in the left 19-49%.Reintervention has been scheduled.Patient status was not reported.After the initial report additional information was received reporting that reintervention was completed with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Additionally, the clinical evaluation determined that the reported indeterminate endoleak was a type iiib of the afx bifurcated stent graft.

• Brand Name: AFX
• 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: 15254930
• MDR Text Key: 298199587
• Report Number: 2031527-2022-00205
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1136114-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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 INFRARENAL AORTIC EXTENSION (1196514-006)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male