MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-80/I20-40

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Paraplegia (2448)

Event Date 02/03/2022

Event Type  Injury  

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 as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows no known device failure reported was identified.This is consistent with the reported adverse event/incident.Procedure related harms for this complaint were reported as ischemia (buttocks); infarction (spinal); hypotension (transient); paraplegia: the reported harms were treated.Unable to identify the contributing factors for the reported procedure related harms due to a lack of medical information.This procedure was an off-label case due to concomitant use with products outside the instructions for use.The final patient status was reported stable 13days post the procedure.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.H6: health effect - clinical code 1983 h3 other text : device remains implanted.

Event Description

The patient was being treated for right common iliac artery (cia) aneurysm on 02 march 2023.The right internal iliac artery (iia) was occluded with coils and gore (non-endologix) excluder leg was implanted in the right external iliac artery (eia).The afx2 bifurcated stent graft and the afx vela suprarenal were implanted from the left access.The final angiogram showed no endoleak.The patient was moved to the icu and complained of severe right buttock pain and right lower limb weakness.The physician determined that the pain was complication after right iia coil occlusion.Paraplegia was suspected of the right lower limb weakness, and a drug was administered.Blood pressure control and oxygen therapy were also performed.On the second day post-procedure, a spinal magnetic resonance imaging was taken, and it showed spinal infarction at t12-l1.After spinal drainage, the right lower limb weakness was improved.Reportedly, multiple vessels around lumbar artery were occluded at once by the endovascular aneurysm repair treatment and the physician stated that this caused these complications.The patient still had intermittent claudication; however, they could walk independently, and they were discharged on the thirteenth day.It should be noted that this procedure was off label due to the absence of an abdominal aortic aneurysm and the use of adjunctive devices not compatible with the afx2 system.

• 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: 19192466
• MDR Text Key: 341155771
• Report Number: 3011063223-2024-00063
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)240907
• 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
• Report Date: 03/29/2024

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: BEA25-80/I20-40
• Device Lot Number: 2504143-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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 (LN 2308516-010); GORE EXCLUDER LEG (LN UNK); UNK COILS (LN UNK)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male