MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888); Failure of Implant (1924); Clinical Endoleak (4843)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted an afx2 bifurcated stent graft an afx vela suprarenal aortic extension and an ovation ix iliac limb to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately 21 months post the initial procedure, a secondary procedure was performed.The physician stated that there is no known endoleak or device issue.The physician wants to perform an elective procedure on the patient to implant an ovation extension in one of the limbs due to placement not being high enough.The initial implant showed good results and there is no alleged device malfunction.Approximately seven and a half (7.5) years post initial procedure, the physician elected to explant the stent grafts for an unknown reason.The explanted stent graft has not been returned to endologix.The patient condition after the explant was not reported.
Additional Manufacturer Narrative
The device involved in this event was not 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 device has not been made available.
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 explanted and was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the explant is confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest aneurysm enlargement of 22 mm, type 3b endoleak of the main body and a type 2 endoleak (non-device related) of the lumbar arteries.The aneurysm enlargement, type 3b endoleak and type 2 endoleak were discovered during review of the operative report dated on (b)(6) 2024.The initial procedure is off-label due to the use of adjunctive devices (ovation limb in right common iliac artery) not compatible with afx system per the ifu.At index, the right common iliac diameter was 28.5mm (should be 10-23 mm) off label.It is unclear if these off ifu conditions contributed to the reported explant.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms are abnormal blood loss (6200cc on (b)(6) 2024).The final patient status was reported as discharged home on postoperative day six.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 corrections: g3: awareness date has been updated, h6: health effect - clinical code: remove code 1924, 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: 19043433
• Report Number: 3011063223-2024-00053
• Device Sequence Number: 7270973
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)170824
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 03/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2017
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 1579972013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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, LOT # 1402288028; OVATION IX ILIAC EXTENDER, LOT # FS122116-06; OVATION IX ILIAC LIMB, LOT # FS012216-34
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male