MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	11/13/2023
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 other text : 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).It was reported that an endurant (non-endologix) aortic extension was implanted first just below the renal artery followed by the afx2 bifurcated stent graft.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.An angiogram showed a type 3 endoleak; however, it could not be determined if the endoleak was a type 3a or type 3b.Touch-up was performed at the stent grafts junction, but the endoleak did not resolve.An afx suprarenal aortic extension was added below the renal arteries.The endoleak resolved and the procedure was completed.Approximately five and half (5.5) years post initial procedure, during follow up aneurysm enlargement was observed and a type 2 endoleak was suspected.An angiogram was performed on 13 november 2023 and showed an endoleak above the bifurcation which determined this to be a type 3b endoleak.No intervention was performed at this time.On 5 december 2023 a secondary procedure was performed where an afx2 bifurcated stent graft was used to reline the previously implanted afx2 and endoleak was successfully resolved.In order to exclude the possibility of a type 2 endoleak, coil embolization of the lumbar artery was done.
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 that the type 3b endoleak, aneurysm enlargement and re-intervention are confirmed.This is consistent with the reported adverse event/incident.Unable to identify the contributing factors for the reported event.This was an off-label case due to concomitant use with products outside the ifu, however it is unclear if this was the contributing factors for the type 3b endoleak.The type 2 (anatomy related) endoleak was treated with coil embolization during re-intervention.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint was a type 2 endoleak from a lumbar artery.The final patient status was not reported post the secondary 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 corrections: g3: awareness date has been 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: 18387145
• Report Number: 3011063223-2023-00055
• Device Sequence Number: 14444919
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)181108
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 11/08/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1756438002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX SUPRARENAL AORTIC EXTENSION, LOT # 1737485022; MEDTRONIC ENDURANT EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female