MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
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.H3 other text: devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and a medtronic (non-endologix) 44x100 thoracic device.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx2 system per device ifu.Approximately three and a half (3.5) years post initial procedure, the patient presented at routine follow-up with a possible type iiib or ib endoleak.The physician plans to reline the main body and possibly place a limb extension in the right common iliac.Surgery has been scheduled for the patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and a medtronic (non-endologix) 44x100 thoracic device.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx2 system per device ifu.Approximately three and a half (3.5) years post initial procedure, the patient presented at routine follow-up with a possible type iiib or ib endoleak.The physician plans to reline the main body and possibly place a limb extension in the right common iliac.Surgery has been scheduled for the patient.Additional information: the physician elected to reline the originally implanted devices with an afx2 bifurcated stent graft, a vela infrarenal aortic extension and an ovation ix extender on (b)(6) 2023 to successfully solve the type 3b endoleak.The patient was reported as doing well.
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 and the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The index procedure is outside the indications of use (off-label) due to adjunctive devices (medtronic 44 x 100 thoracic device) not compatible with the afx2 system per device ifu.This may have contributed to the reported events but could not conclusively be determined.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.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.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G3: awareness date has been updated.H6: health effect - impact code: remove code 4614.H6: medical device problem codes: remove code 4065.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: 17924931
• Report Number: 3011063223-2023-00013
• Device Sequence Number: 16886878
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)200417
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 04/17/2020
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2241297-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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: MEDTRONIC (NON-ENDOLOGIX) THORACIC (44X100) DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female