MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent treatment for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft, two (2) afx limb stent grafts, an afx vela suprarenal, and an ovation ix iliac limb on (b)(6) 2024.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx system per the ifu.On (b)(6) 2024, the patient presented to the hospital with a reported kink in the left limb.The physician opted to address this issue by performing balloon angioplasty and placing a balloon-expandable stent.The patient's post-operative condition was reported as "ok" post-op.
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 afx with duraply.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.The device was not returned to endologix for evaluation because it remains implanted.Medical imaging received by endologix shows the afx left limb extension buckled stent and stenosis of the left common iliac artery complaints are confirmed.The additional endovascular procedure complaint is also confirmed.This is consistent with the reported adverse event/incident.The preexisting angulation in the left iliac artery near the hypogastric likely contributed to the stent buckling and stenosis (anatomy-related).The concomitant product use of an ovation limb in the right iliac artery did not appear to contribute to the reported event.The complaint is most likely anatomy-related.Procedure-related harms of this complaint could not be determined with the medical records available for review.The final patient status was reported as doing okay post-secondary intervention.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 afx with duraply.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• Common Device Name: LIMB 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: 19484720
• Report Number: 3011063223-2024-00082
• Device Sequence Number: 7906020
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)240618
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/15/2024

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: 06/18/2024
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 2479354-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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 LIMB STENT GRAFT LOT #: 2492872R002.; AFX VELA SUPRARENAL LOT #: 2751849021.; AFX2 BIFURCATED STENT GRAFT LOT #: 2736596003.; OVATION IX ILIAC LIMB LOT #: FS091823-60.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male