MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I16-40

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 12/28/2022

Event Type  Injury  

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 h3 other text : device remains implant.

Event Description

Afx2 bifurcated device implant procedure; device wouldn¿t advance into the tight aorta.The physician elected to retract the afx2 device back into the introducer sheath and in doing so the distal part of the sheath created a kink in the component.Extravasation was noticed and the patient's blood pressure dropped.An open repair of the external iliac was performed.The final patient status was reported as doing good.

Manufacturer Narrative

The reported 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 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 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 afx 2, introducer device damaged during use, difficult to withdraw, and kinked components are confirmed.This is consistent with the reported event/incident.The complaint is most likely user related.The identified harms related to the procedure include an avulsed right external iliac artery and a common femoral artery which required an additional surgical procedure for open repair of the right external iliac artery.It is noteworthy that there was no abdominal aortic aneurysm and aortoiliac occlusive disease (off-label), which may have contributed to the reported event.This case was an off-label intervention with a right common iliac artery distal diameter of 7.1mm and a left common iliac artery distal diameter of 9.1mm lcia d 9.1mm (which should be within 10-23mm range).The minimal access on the right was 4.2mm and on the left was 4.2 mm (which should be greater than 6.5mm, off-label), and this likely contributed to the reported events.The neck diameter was 12.7 mm (which should be within 18-32mm range, off-label).Furthermore, the presence of thickened calcifications in the right common iliac artery was found to have likely contributed to the reported avulsion (perforation).The final patient status was reported as doing good.No additional investigation of this reported 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 events/incidents.Device iteration is afx2.G3: date of received by manufacturer has been updated h3: reason device not evaluated has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion code: 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: 16219600
• MDR Text Key: 307875738
• Report Number: 2031527-2023-00010
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015013
• UDI-Public: (01)00818009015013(17)231006
• 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: 12/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: BEA22-60/I16-40
• Device Lot Number: 2392704-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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 AFX INTRODUCER SYSTEM II 2491555014; AFX INTRODUCER SYSTEM II 2489353009; AFX2 BIFURCATED STENT GRAFT 2582018006; OVATION IX EXTENDER FS050322-48
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female