MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-70/I20-30

Device Problem Separation Problem (4043)

Patient Problems Abdominal Pain (1685); Ruptured Aneurysm (4436)

Event Date 12/02/2023

Event Type  Injury  

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, endologix practices making 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 that the device was properly manufactured and released in accordance with the device master record.The review confirms that 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 that type iiia endoleak, rupture, and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The 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 was reported to be in stable condition.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 afx2.

Event Description

The patient underwent treatment for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft, afx vela suprarenal, and a gore (non-endologix) excluder.This initial procedure falls outside the indications for use (off-label) due to the utilization of adjunctive devices that are not compatible with the afx system.Approximately three and a half (3.5) years post the initial procedure, the patient reported experiencing chest and stomach pain since the end of november 2023.The patient lost consciousness and was transferred to another hospital on (b)(6), 2023.A computed tomography (ct) scan revealed implant separation, an endoleak type iiia and intra-abdominal bleeding, resulting in the diagnosis of a rupture (aorta).The patient was then transferred to another hospital, where an emergency re-intervention took place.During this procedure, a gore (non-endologix) ctag was implanted under the renal artery, and two (2) gore (non-endologix) excluder cuffs were added.It was reported that the re-intervention effectively resolved the endoleak type iiia.The final patient status was reported as stable.

• Brand Name: AFX2
• 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: 18465790
• MDR Text Key: 332326166
• Report Number: 3011063223-2024-00002
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)230214
• 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: 12/07/2023

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: 02/14/2023
• Device Model Number: BEA28-70/I20-30
• Device Lot Number: 2332682-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2020
• 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-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (B)(6).; GORE (NON-ENDOLOGIX) EXCLUDER (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Sex: Male