MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I20-40
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2018, during which an afx2 bifurcated stent graft, an afx vela suprarenal, and two (2) ovation ix extenders were implanted.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 instructions for use (ifu).On (b)(6) 2024, the physician reported suspicion of an endoleak type iiib.Reintervention is scheduled for on (b)(6) 2024.
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.
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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirms the afx2, type iiib endoleak complaint.The additional endovascular procedure is also confirmed, which is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a buckled main body stent with fracture and sac growth of 6mm also occurred.The buckled stent, fracture, and sac growth were discovered during a review of the computed tomography (ct) scan dated april 5, 2024.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.This initial procedure is outside the indications of use due to the use of concomitant devices (ovation extensions bilateral limbs) not compatible with the afx system.It is unclear if this contributed to the reported event.The final patient status was discharged on post-operative day one, home in stable condition.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: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) procedure on (b)(6) 2018, during which an afx2 bifurcated stent graft, an afx vela suprarenal, and two (2) ovation ix extenders were implanted.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 instructions for use (ifu).On (b)(6) 2024, the physician reported suspicion of an endoleak type iiib.Reintervention is scheduled for (b)(6) 2024.Additional information: on (b)(6) 2024, the patient underwent a re-intervention during which the physician elected to implant an afx2 bifurcated stent graft and an afx vela suprarenal device.The patient was discharged on postoperative day one and returned home in stable condition.

• 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: 19216408
• Report Number: 3011063223-2024-00065
• Device Sequence Number: 12810654
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)190313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2024

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: 03/13/2019
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1821706-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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: AFX VELA SUPRARENAL 1813130-009.; OVATION IX EXTENDER FS020318-34.; OVATION IX EXTENDER FS072617-53.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female