MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-80/I20-40

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Ruptured Aneurysm (4436)

Event Date 01/28/2024

Event Type  Death  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation as they were explanted and not returned by the hospital.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 afx2.H3 other text: device discarded by the hospital.

Event Description

An emergency endovascular aneurysm repair (evar) was performed on (b)(6) 2024 for a rupture.Reportedly, the patient was very obese.The endologix representative was not present at the case; however, was called via facetime when the afx2 bifurcated stent graft (bsg) main body was in the aorta and snared with the afx2 bsg limbs appearing to be wrapped.The physician was attempting to orientate the afx2 bsg limbs to get them unwrapped.However, the afx2 bsg limbs could not be separated after approximately 30 minutes and the decision was made to abort and open.The staff was doing some compressions as the patient coded on the table a couple times.This made it more challenging to see what was happening on the screen.The patient was opened and the afx2 bsg was explanted.The physician continued to try and save the patient.The patient expired approximately five hours post-explant.The explanted devices were not returned by the hospital.

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 was explanted and discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the ruptured abdominal aortic aneurysm, intraoperative unable to deploy stent graft, surgical conversion with explant and death complaints are confirmed.This is consistent with the reported adverse event/incident.The patient death was determined to be anatomy related (aortic rupture pre procedure).There was cautionary usage as this was an emergent procedure due to the ruptured abdominal aortic aneurysm and hemodynamic instability (having received 8 units of blood preoperatively).Additionally, it was reported the patient was very obese.Cpr was done prior to the main body being placed.Procedure related harms were prolonged procedure and hemodynamic instability.The final patient status was reported as deceased.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.Corrections: g3: awareness date ¿ updated.H1: type of reportable event - corrected.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• 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: 18754462
• MDR Text Key: 335933469
• Report Number: 3011063223-2024-00020
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2024

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 Model Number: BEA28-80/I20-40
• Device Lot Number: 2693065010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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: OVATION IX ILIAC LIMB (LN FS081023-58).
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Male