MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-100/I20-40

Device Problems Appropriate Term/Code Not Available (3191); Lack of Effect (4065)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208); Paraplegia (2448)

Event Date 12/06/2022

Event Type  Death  

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm.After the initial procedure, type ii endoleak (non¿device-related failure) was observed, and the patient was being monitored when an aneurysm enlargement was identified.It is now suspected the patient has an endoleak type ib.The physician is planning on performing a re-intervention.

Manufacturer Narrative

The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 type ii endoleak (non-device related issue), type ib endoleak from the left common iliac artery, and aneurysm enlargement are confirmed.The additional endovascular procedure, paraplegia, rupture, and death are unconfirmed.This is moderately consistent with the reported adverse event/incident.According to the medical report, during the dryseal graft (non-endologix device) insertion procedure, significant resistance was encountered around the terminal aorta, which required the application of force to advance the graft.Following the procedure, the patient awakened from anesthesia with paraplegia in both legs and abdominal pain.The attending physician has commented on the case, stating that the afx2 may have migrated upward during the dryseal (non-endologix device) insertion, potentially moving into the aneurysm and causing a rupture.The severity of the rupture suggests that surrounding organs were also likely damaged, and the presence of thrombi in the false lumen further complicates the case.There is a possibility that clots may have blocked brain vessels, which could have contributed to the patient's symptoms, although this could not be definitively determined due to a lack of relevant records and imaging.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 being 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: b2: outcomes attributed to ae.B5: describe event or problem.G3 awareness date.H1: type of reportable event.H6 health effect - clinical code; remove 1924.H6 medical device problem codes; remove 3191.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm.After the initial procedure, type ii endoleak (non¿device-related failure) was observed, and the patient was being monitored when an aneurysm enlargement was identified.It is now suspected the patient has an endoleak type ib.The physician is planning on performing a re-intervention.Additional information: the patient underwent a re-intervention.During the procedure, a dryseal (non-endologix device) was introduced via the left femoral artery.Following this, three excluder devices were implanted, and subsequent angiography indicated no signs of endoleak.Following the procedure, the patient expressed an inability to move their lower extremities, leading the attending physician to suspect the onset of paraplegia.Additionally, the patient complained of abdominal discomfort.The physician promptly administered an anesthetic and closely monitored the patient for any abnormal observations.Unfortunately, the patient passed away two (2) days later.It was also reported that the patient suffered an aorta rupture.Regrettably, further data regarding this case is currently unavailable.

• 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: 16077638
• MDR Text Key: 306423293
• Report Number: 2031527-2022-00293
• Device Sequence Number: 1
• Product Code: MIH
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2022

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 Expiration Date: 11/30/2019
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1763614-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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 VELA SUPRARENAL 1767266-007.
• Patient Outcome(s): Other; Death