MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20V

Device Problems Off-Label Use (1494); Separation Problem (4043)

Event Date 01/31/2024

Event Type  Injury  

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal aortic extension.It was noted that the patient originally had an occluded left internal iliac artery; therefore an (non-endologix) gore excluder iliac leg was implanted in the left external iliac artery prior to implant of the afx devices.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.Approximately three (3) years post initial procedure, during routine follow-up the afx vela was found to have migrated and there was a type 1a endoleak observed.The next day the physician elected to perform a secondary procedure and a (non-endologix) fenebranch thoracic endovascular aortic repair (tevar) device was implanted.A (non-endologix) alpha stent graft was also added.As there was a type 3a endoleak between the afx2 and the vela, two (2) non-endologix excluder cuffs were implanted.The volume of the type 3a endoleak was decreased after this secondary intervention and the procedure was concluded.

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 cuff migration is confirmed; however, type 1a endoleak and type 3a endoleak are unconfirmed.This is moderately consistent with the reported adverse event/incident.Unable to identify the contributing factors due to a lack of the medical information surrounding the event.Unable to identify the type of endoleak from a non diagnostic still photo.This was an off-label case due to concomitant use with products outside the ifu.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported post the re-intervention.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 h3 other text : device remains implanted.

• 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: 18796501
• MDR Text Key: 336409576
• Report Number: 3011063223-2024-00025
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/06/2024

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 Expiration Date: 02/25/2023
• Device Model Number: A34-34/C100-O20V
• Device Lot Number: 2335424004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT, LOT # 2277777003; GORE EXCLUDER (NON-ENDOLOGIX) ILIAC LIMB
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male