MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I16-40
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	06/23/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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.Device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft vela infrarenal extension, a non-endologix cuff and a non-endologix bare metal stent (off-label) to treat an abdominal aortic aneurysm.During the contralateral leg deployment of the bifurcated stent graft, the contralateral wire was pulled too strongly causing the device to move towards the contralateral leg.During the afx vela infrarenal delivery system retrieval, the system became stuck at the stent graft skeleton causing the stent deformation around the thoracic aorta.The resistance was felt twice during the afx vela infrarenal delivery system retrieval.A balloon was inserted from the contralateral side and the delivery system was retrieved with ballooning.The afx vela infrarenal was moved downward about 20mm during the delivery system retrieval; therefore, a gore (non-endologix) cuff was implanted at the proximal portion.Reportedly, the patient¿s vessel condition and both external iliac arteries were not in good condition with dissections and thrombosis.The angiography showed no endoleak and the operation was completed.Reportedly, the patient died 2 days post initial procedure due to multiple organ failure.
Additional 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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because 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 the afx2 bifurcated stent graft implant difficulty, caudal proximal extension migration of approximately 20mm, multiple organ failure and death related to abdominal aortic aneurysm are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this adverse event/incident could not be determined.Procedure related harms for this adverse event/incident could not be determined; however, the reported patient death was most likely procedure related.The reported concomitant use of a non-endologix gore cuff and non-endologix bare metal stents in the iliac arteries is off label.It is unclear if this contributed to the reported adverse event/incident.Reportedly, there was a lot of thrombi at the proximal neck.The tortuous right common iliac vessel and both external iliac arteries were not in good condition with dissections and thrombosis.This also could have contributed to the reported adverse event/incident.The final patient status was reported to be deceased two days post 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.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Common Device Name: 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: 15133410
• Report Number: 2031527-2022-00196
• Device Sequence Number: 17762788
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)240830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2024
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 2503094-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL (LN 2401943-002).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male