MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-90/I16-30

Device Problem Insufficient Information (3190)

Patient Problems Ischemia (1942); Necrosis (1971); Multiple Organ Failure (3261); Embolism/Embolus (4438)

Event Date 08/12/2022

Event Type  Death  

Event Description

The patient was initially implanted with a bifurcated stent graft and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).It was reported that the patient had poor anatomy, described as severe calcification and a narrowed external iliac artery (eia).After the stent grafts were implanted the procedure was completed without any endoleaks.Four (4) days post implant a shower embolization event occurred and the patient deteriorated to a fatal condition.Per the physician, the internal iliac arteries (iia) were also found embolized.The patient's blood pressure changed and necrosis was observed in the lower legs at the time of the shower embolization.Dialysis was performed at that time.It was reported that the patient expired four days post implant.The cause of death is multi organ failure due to intestinal ischemia.Both the iia and the inferior mesenteric artery (ima) were occluded at the same time when the stent grafts were implanted and because of thrombi which could have lead to the ischemia event.

Manufacturer Narrative

The device involved in this 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 afx2.Device remains implanted.

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 review confirms 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 the shower embolization is confirmed.The patient death is unconfirmed due to a lack of relevant medical information.This is moderately consistent with the reported adverse event/incident.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.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.G3: date of received by manufacturer.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: 15341900
• MDR Text Key: 299137337
• Report Number: 2031527-2022-00218
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)50125
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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: BEA22-90/I16-30
• Device Lot Number: 2543437-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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 INFRARENAL AORTIC EXTENSION, LOT # 2540228-005.
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Male