MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number I20-13/C88F SA

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Respiratory Failure (2484)

Event Date 02/28/2024

Event Type  Injury  

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, afx limb stent graft, and an afx vela suprarenal proximal extension on (b)(6) 2024.Following this procedure, the patient was readmitted to the hospital later the same day for a groin repair.Computed tomography scan identified partial occlusion of the right iliac limb.Reintervention plans were not provided.The patient was reported to be on a ventilator.

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 duraply.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's 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the right limb occlusion complaint is refuted and determined to be an access site complication with additional surgical procedure returning to the operating room 1 hour postoperatively; the patient was not readmitted.This is not consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest retroperitoneal hematoma occurred that was not included in the event as reported.The retroperitoneal hematoma was discovered during review of the computed tomography (ct) scan dated on (b)(6) 2024.At index, there was difficulty accessing the right common femoral artery with small extravasation noted.Due to periodic hypotension, a cutdown of the right common femoral artery was performed and bleeding was controlled.The patient then returned to the operating room one hour postoperatively for bleeding in the posterior artery that had been previously stitched.It was felt that stitches had been pulled out through the closure site making this an access site complication.This was re-sutured and closed with no further bleeding.There was no mention of a limb occlusion in the operative report.There was no evidence of infection or occlusion on the ct scan dated on (b)(6) 2024.There was however evidence of a 10.8cm retroperitoneal hematoma.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms were acute kidney injury (requiring dialysis), abnormal blood loss (received 2 units prbc's intra op), hemodynamic instability (hemorrhagic shock requiring pressers and blood), respiratory insufficiency (prolonged ventilator) and additional endovascular procedure (right groin cut down).The final patient status was reported as discharged to rehabilitation on postoperative day 22.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: g3 awareness date has been updated , b2: outcomes attributed to adverse events has been updated , b5: describe event or problem has been updated , h6 investigation finding codes; remove 3233, h6 investigation conclusion codes; remove 11, h6 health effect - clinical code ; remove 2422, h6 medical device problem codes ; remove 2423, h6: component codes ; remove 515.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, afx limb stent graft, and an afx vela suprarenal proximal extension on (b)(6) 2024.Following this procedure, the patient was readmitted to the hospital later the same day for a groin repair.Computed tomography scan identified partial occlusion of the right iliac limb.Reintervention plans were not provided.The patient was reported to be on a ventilator.Additional information: the clinical evaluation of the adverse event revealed that the initial complaint of right limb occlusion was incorrect and instead identified an access site complication.Medical records and imaging showed no evidence of limb occlusion but did reveal a retroperitoneal hematoma from a computed tomography (ct) scan dated (b)(6) 2024.The complication arose due to difficulties in accessing the right common femoral artery, leading to periodic hypotension and necessitating additional surgery to control bleeding.The patient returned to the operating room an hour postoperatively for re-suturing at the right common femoral artery.The patient experienced several procedure-related complications, including acute kidney injury requiring dialysis, abnormal blood loss, hemorrhagic shock, prolonged ventilation, and a right groin cutdown.The patient was discharged to rehabilitation on postoperative day 22.

• Brand Name: AFX
• Type of Device: LIMB 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: 18954196
• MDR Text Key: 338307128
• Report Number: 3011063223-2024-00039
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)240707
• 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: 02/29/2024

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: I20-13/C88F SA
• Device Lot Number: 2484937-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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 VELA SUPRARENAL 2753302021; AFX2 BIFURCATED STENT GRAFT 2735519010
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male