MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Fracture (1260); Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problems Aneurysm (1708); Ruptured Aneurysm (4436)

Event Date 10/02/2023

Event Type  Death  

Manufacturer Narrative

The devices involved in this event will be returned for evaluation.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 strata.

Event Description

Endologix was made aware by medwatch (mw5146650) of a patient initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately nine and a half (9.5) years post initial procedure, the patient presented with a fabric tear (classified as a type iiib endoleak) and an aneurysm sac rupture.The physician elected to treat the patient by explanting the devices on an unknown date.The patient subsequently passed away.No additional information is currently available regarding this initial report.

Event Description

Endologix was made aware by medwatch (mw5146650) of a patient initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately nine and a half (9.5) years post initial procedure, the patient presented with a fabric tear (classified as a type iiib endoleak) and an aneurysm sac rupture.The physician elected to treat the patient by explanting the devices on an unknown date.The patient subsequently passed away.No additional information is currently available regarding this initial report.Additional information: subsequent to the initial report, additional information was provided reporting that the date of explant and death are (b)(6) 2023.A clinical evaluation was conducted, revealing evidence indicating an aneurysm enlargement of 33.9mm and a stent fracture of the proximal extension.These findings were found upon an examination of the ct (computed tomography) study dated (b)(6) 2023.

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 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.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 afx, aneurysm rupture, and surgical conversion with explant is unconfirmed.The type iiib endoleak of the proximal component and main body are confirmed.The death complaint is also confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an aneurysm enlargement of 33.9mm and a stent fracture of the proximal extension also occurred.The aneurysm enlargement and stent fracture were discovered during a review of the ct (computed tomography) study dated 02 october 2023.The use of strata material likely 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 was reported as deceased.A root cause investigation was conducted for all afx complaints that had an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events: 1.Upgraded graft material (i.E., duraply) and 2.Updates to the instructions for use (ifu) and additional physician training.The change to duraply graft material and the ifu changes were implemented in july 2014.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 strata.Corrections: h6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• 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: 18044219
• MDR Text Key: 327017021
• Report Number: 3011063223-2023-00026
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1055816-005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL, SN (B)(6).
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male