MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A28-28/C95-O20V

Device Problems Off-Label Use (1494); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2022

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 duraply.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix iliac limb.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.Approximately five (5) years post initial procedure, at the sixty (60) month routine follow-up, a type ia endoleak was identified within the stent body between the metal struts and the graft material.Reintervention plans were not made available.The patient status was not reported.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix iliac limb.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.Approximately five (5) years post initial procedure, at the sixty (60) month routine follow-up, a type ia endoleak was identified within the stent body between the metal struts and the graft material.Reintervention plans were not made available.The patient status was not reported.Additional information: a clinical assessment determined that there was evidence to suggest implant movement of the proximal extension of 5.9mm also occurred.The stent movement was discovered during a review of the computed tomography (ct) scan.

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.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 is confirmed as an endoleak at indeterminate origin.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest implant movement of the proximal extension of 5.9mm also occurred.The stent movement was discovered during a review of the computed tomography (ct) scan.Clinical evaluation also confirmed the concomitant product use of an ovation limb with an afx bifurcated stent graft, and an aortic neck diameter of 17.9mm (ifu requirement is 18-32mm); these are off-label conditions, but it is unclear if they contributed to the reported event.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• 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: 15337167
• MDR Text Key: 299079657
• Report Number: 2031527-2022-00216
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)191109
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1613819-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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: AFX2 BIFURCATED STENT GRAFT (LN 1491493-029); OVATION IX ILIAC LIMB (LN FS010416-04)
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male