MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I20-30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	07/08/2023
Type of Reportable Event	Death
Event or Problem Description
The patient was emergently treated for a ruptured abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.While the patient was stabilized prior to the initial implant, this procedure is outside the indications of use (off-label) due to emergent use of the afx2 system per device ifu.During the initial implant procedure and upon femoral access, the patient ruptured again and became unstable.The physician quickly implanted the main body, after which the patient stabilized.The proximal extension was then implanted, and a full seal obtained.However, due to the high blood volume loss, the patient ultimately passed away one (1) day post procedure.
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.
Event or Problem Description
The patient was emergently treated for a ruptured abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.While the patient was stabilized prior to the initial implant, this procedure is outside the indications of use (off-label) due to emergent use of the afx2 system per device ifu.During the initial implant procedure and upon femoral access, the patient ruptured again and became unstable.The physician quickly implanted the main body, after which the patient stabilized.The proximal extension was then implanted, and a full seal obtained.However, due to the high blood volume loss, the patient ultimately passed away one (1) day post procedure.Additional information: internal clinical assessment identified that an intraoperative endoleak (at an indeterminate origin) was also present and that patient required a blood transfusion.The patient death was deemed unrelated to an endologix device due to the ruptured aneurysm that was present prior to initial implant with afx devices.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.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 reported afx2 (emergent use) due to abdominal aortic aneurysm rupture, acute blood loss (requiring mtp (mass transfusion protocol)) and death are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest that post deployment of the bifurcated stent graft and proximal extension, an endoleak at indeterminate origin (either type ia or non-device-related type ii endoleak) occurred that was not in the event as reported.This finding was discovered during an examination of the angiogram dated (b)(6) 2023.The most likely causation for the reported death is anatomy-related and unrelated to the device, procedure or use environment; the ruptured aneurysm was pre-existing before arrival in the operating room (cautionary product use condition), which resulted in a large loss of blood volume incompatible with life.In addition, it was noted that the patient was severely hypotensive with a distended abdomen (probable compartment syndrome) during the stent deployment.The blood loss (of 2500ml), rupture and hemodynamic instability were related to the pre-existing rupture and not the device.Also, while the proximal aortic neck was noted as off-label, this did not appear to contribute to the reported event.The procedure-related harm identified was the indeterminate endoleak.The final patient status was pronounced deceased in the operating room.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.Corrections: b5 describe event or problem g3 awareness date h6 health effect - clinical code; remove 4436 h6 medical device problem codes; remove 2993 h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 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: 17344086
• Report Number: 2031527-2023-00185
• Device Sequence Number: 15090188
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)230820
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2023

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: 08/20/2023
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2379081-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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 SUPRARENAL, SN (B)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Unknown