MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-60/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Aneurysm (1708); Obstruction/Occlusion (2422); Clinical Endoleak (4843)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for a dissecting saccular aneurysm of the terminal aorta (ta) on (b)(6) 2019.During the initial procedure, an afx2 bifurcated stent graft was implanted.A balloon touch-up was performed to address a bird-beak configuration.A non-endologix stent (protage 12-6.0) was placed in the left leg to prevent occlusion.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system per the ifu.The procedure concluded successfully without any signs of endoleaks.In (b)(6) 2024, a follow-up computed tomography (ct) scan revealed that there was aneurysm diameter enlargement, from 38 mm in diameter to over 50 mm in diameter due to an endoleak of indeterminate origin.On (b)(6) 2024, open surgery repair was performed.The afx2 bifurcated stent graft was explanted and converted to a non-endologix y-shaped artificial vessel.It was noted that multiple holes (type iiib endoleak) were found in the afx2 bifurcated stent graft.The final patient status was not made available to endologix.
Additional Manufacturer Narrative
The explanted stent graft will be 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 h3 other text: pending device return.
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 returned device was completed.A visual and where possible functional analysis was performed.Endologix received one (1) afx2 bifurcated stent graft for evaluation.A comprehensive assessment was conducted on the returned devices, which were securely packaged in a box and transported in a biohazard containment bag.Before evaluation, the devices underwent a decontamination process to eliminate potential contaminants.Upon visual inspection of the afx2 bifurcated stent graft, it was observed that a puncture/tear was identified on the distal section of the graft.This finding corresponds to characteristics indicative of a type iiib endoleak.The reported damage (type iiib endoleak) was confirmed based on the identification of a puncture/tear within the afx2 bifurcated stent graft material.It is important to note that the damage may have also occurred during the explant procedure.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiib endoleak.Surgical conversion and explant are confirmed.The aneurysm enlargement is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a right common iliac artery occlusion also occurred.The right iliac artery limb occlusion was discovered during a review of the 21-second computed tomography (ct) scan video.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.There was concomitant product usage of a non-endologix stent in the left limb (off-label).It is unclear if this contributed to the reported event.The final patient status was not reported, however, it was reported that the procedure concluded successfully without any signs of endoleak.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: date received by manufacturer has been updated.H3: device evaluated by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: 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: 20857950
• Report Number: 3011063223-2024-00170
• Device Sequence Number: 18299511
• Product Code: MIH
• UDI-Device Identifier: 00818009014740
• UDI-Public: (01)00818009014740(17)201009
• 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: 2019
• Device Explanted Year: 2024
• 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): 11/14/2024

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: 10/09/2020
• Device Model Number: BEA25-60/I16-40
• Device Lot Number: 1995803003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2018
• 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: PROTAGE 12-6.0, NON-ENDOLOGIX STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male