MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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: device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately three (3) hours after post initial procedure the physician indicated that the graft had become occluded.To address this issue the physician implanted two (2) ovation ix extender(s) and two gore (non-endologix device) vbx stent grafts to support the limbs, extending them beyond their original positions.The grafts are currently functioning well, and the patient's condition is reported as stable.
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.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 afx2, occlusion within the device (aortic and iliac) and additional endovascular procedure immediately post operative on june 16, 2023 are confirmed.The complaint is most likely anatomy- and user-related.This is consistent with the reported adverse event/incident.The procedure-related harms are limb ischemia, respiratory complication- (ventilator-dependent hypoxic respiratory failure with tracheostomy), sigmoid colon ischemia resulting in perforation and sepsis, and six additional surgical procedures.The clinical evaluation also shows reasonable evidence to suggest six additional surgical procedures, an ischemic bowel with perforation and sepsis, and respiration complications also occurred.These events were discovered on august 03, 2023, during a review of the serial operative reports.It was noted that the patient was being treated emergently at the index for a painful, cold, blue foot that had been present for at least 2 weeks and possibly longer (pre-existing condition), which is considered anatomy-related.At the time of the index procedure, the computed tomography (cat) scan showed critical left limb ischemia with left iliac embolism, and the aortic grafts (afx main body and non-endologix stents) were used to cage the thrombus.There was no abdominal aortic aneurysm (off-label) which is considered user-related.The patient experienced sigmoid colon ischemia which resulted in perforation and sepsis, and mesenteric ischemia is a known adverse event associated with an evar procedure.However, it is unknown if the mesenteric ischemia was related to possible coverage of the internal mesenteric artery during the evar.The left internal iliac artery was also intentionally covered at the index and it was reported the bifurcation was heavily calcified; it is unclear if this contributed to the reported event.The final patient status was reported as doing well.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: 17302554
• Report Number: 2031527-2023-00176
• Device Sequence Number: 15198220
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)260123
• 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): 06/16/2023

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: 01/23/2026
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 2646826-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: GORE VBX STENT GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female