MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Unintended Movement (3026); Separation Problem (4043)
Health Effect - Clinical Codes	Hematoma (1884); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2022 with the implant of an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal.The afx vela suprarenal migrated down, and an excluder (non-endologix) stent was added just below the lower renal artery.The afx2 bsg and afx vela suprarenal overlap length was about three segments (around 55mm).There was no impact to patient reported.The patient attended a regular follow-up computed tomography (ct) scan every year and echocardiography with no endoleaks detected.On (b)(6) 2024, the patient visited a different hospital due to stomachache.A simple ct scan showed retroperitoneal hematoma, the patient returned to the implanting hospital.A contrast ct showed aneurysm rupture due to a type iiia endoleak with separation of afx2 bsg and the afx vela suprarenal.An emergent reintervention was performed with the implant of an excluder aorta extension at the junction.In addition, a gore (non-endologix) ipsilateral leg, gore (non-endologix) contralateral leg, gore (non-endologix) iliac extender, and a gore (non-endologix) contralateral leg were implanted under the renal arteries.The final patient status was not provided.Note: the afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
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, follow-up report will be submitted.Device iteration is afx2.
Additional Manufacturer Narrative
The reported 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.Endologix was unable to perform an evaluation of the device as it was not returned from the user facility.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix found the ruptured aneurysm and additional endovascular procedure complaints are unconfirmed.The type iiia endoleak complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The procedure is outside the indications of use (off-label) due to the use of adjunctive devices (gore excluder leg) not compatible with afx system per the ifu.The clinical evaluation also shows reasonable evidence to suggest the infrarenal angulation progressively increased each year which likely contributed to the implant separation.It is unclear if this angulation occurred due to aortic remodeling or if related to the non endologix cuff.The final patient status was reported as stable.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 ¿ 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: 19913609
• Report Number: 3011063223-2024-00121
• Device Sequence Number: 8104462
• Product Code: MIH
• UDI-Device Identifier: 00818009014733
• UDI-Public: (01)00818009014733(10)200625
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 06/25/2020
• Device Model Number: BEA25-80/I16-40
• Device Lot Number: 2265267018
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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: AFX VELA SUPRARENAL (LN 2286470006).; GORE (NON-ENDOLOGIX) EXCLUDER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male