MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A28-28/C75-O20V

Device Problem Migration (4003)

Event Date 03/25/2024

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, follow-up report will be submitted.Device iteration is afx with duraply.H3 other text: device remains implanted.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2015 with the implant of an afx bifurcated stent graft, two afx vela infrarenal, and an afx vela suprarenal.It was reported on (b)(6) 2024 that routine follow up identified migration of the afx vela suprarenal with a type ia endoleak.Reintervention was performed with the implant of an alto abdominal stent graft system on (b)(6) 2024, resolving the type ia endoleak.The patient was to be discharged one day post-reintervention.

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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the implant migration (cuff) complaint is unconfirmed.The type ia endoleak with additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint cannot be determined.Procedure related harms could not be determined.Migration could not be determined due to lack of comparative imaging.There was revision of a previously placed graft which is cautionary product usage.The final patient status was reported as discharged home on postoperative day one with resolution of endoleak.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 ¿ updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• 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: 19192584
• MDR Text Key: 341241876
• Report Number: 3011063223-2024-00058
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)151008
• 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
• Report Date: 04/02/2024

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: 10/08/2015
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1252016013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2014
• 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 BIFURCATED STENT GRAFT (LN 1251748019); AFX VELA INFRARENAL (LN 1164390006); AFX VELA INFRARENAL (LN 1164423002)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male