MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/18/2021
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal and an afx limb stent graft.Approximately two and a half (2.5) years post initial procedure routine follow up computed tomography identified aneurysm enlargement and a type ib endoleak of both iliac limbs.Reintervention is scheduled; however, has not yet taken place.The patient is reported to be in good condition.
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.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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The iliac limbs were rcia 28.3mm and lcia 23.3mm (ifu states 10mm-23mm).Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being in good 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 afx with durably.B6: relevant test/lab data - updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.
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.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the additional endovascular procedure (ct evidence of addition of bilateral iliac stents) is confirmed.The bilateral type ib endoleaks and the sac growth are unconfirmed.This is moderately consistent with the reported adverse event/incident.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The iliac limbs were rcia 28.3mm and lcia 23.3mm (ifu states 10mm-23mm).This very likely could have caused the bilateral type ib endoleaks but that could not be conclusively determined.Additionally, there was significant tortuosity of the left iliac artery, this could have contributed to the reported event but could not be conclusively determined.The final patient status was reported as being in good 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 afx with duraply.Corrections: b2: outcomes attributed to ae ¿ updated.B5: describe event or problem ¿ updated.B6: relevant tests and lab data - updated.G3: awareness date ¿ updated.H6: health effect - impact code ¿ remove 4614.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal and an afx limb stent graft.Approximately two and a half (2.5) years post initial procedure routine follow up computed tomography identified aneurysm enlargement and a type ib endoleak of both iliac limbs.Reintervention is scheduled; however, has not yet taken place.The patient is reported to be in good condition.After the follow-up report, additional information was received that on an unknown date, the physician treated the bilateral type ib endoleaks by extending both the right and the left iliac limbs.Further information for this intervention is not available.

• 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: 12924419
• Report Number: 2031527-2021-00482
• Device Sequence Number: 11988539
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)200810
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2021

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: 08/10/2020
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1727526001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/19/2022; 10/06/2023
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/27/2022; 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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 VELA SUPRARENAL (LN 2138595004); AFX2 BIFURCATED STENT GRAFT (LN 2037874001)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male