MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-120/I16-40

Device Problem Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Rupture (2208)

Event Date 06/24/2021

Event Type  Death  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the 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 initially implanted with an afx bifurcated stent graft and vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately (6) six years after post initial procedure, the patient was submitted to the hospital due to a renal aortic rupture.The leak was never contained and the patient expired on (b)(6) 2021.A computed tomography angiography (cta) scan was done and it showed that the patient had implant movement and a sac growth with significant amounts of contrast outside of the stent margins suggesting a large endoleak.

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 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 indeterminate endoleak, sac growth, rupture, secondary endovascular procedure, and death are confirmed.This is consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The procedure/rupture-related harm identified was hemodynamic instability.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.G4: date of received by manufacturer - updated.H6: result code - remove code 3233.H6: conclusion code - remove code 11.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12155497
• MDR Text Key: 261189448
• Report Number: 2031527-2021-00263
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014184
• UDI-Public: (01)00818009014184(17)171015
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2017
• Device Model Number: BA28-120/I16-40
• Device Lot Number: 1283291-012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL 1252395-020.
• Patient Outcome(s): Death
• Patient Age: 91 YR