MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2022
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 afx2.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix iliac limb.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.Reportedly, at the initial procedure, the patient had a right common iliac aneurysm and the physician elected to land on th left in order to spare the left internal.Approximately four (4) years post initial procedure, routine follow-up identified a type ib endoleak in the left common iliac artery with the aneurysm at 25mm.Reintervention has been scheduled.The patient is reported to be stable.
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 the device remains implanted.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 ib endoleak with aneurysm enlargement is unconfirmed.Device, user, or procedure relatedness of this adverse event/incident could not be determined with the medical records available for review.Definitive anatomy relatedness could not be determined; however, there was bilateral iliac aneurysms at index, maximum right 3.8cm left 2.8cm.This could have contributed to the reported type ib endoleak with aneurysm enlargement.Though, the distal diameters measured on label (right 12mm and left 19mm).The rate of left iliac sac growth from 09/07/2018 to 08/19/2022 was 2.9mm.During the investigation, endologix found reasonable evidence to suggest the device was used off-label as the abdominal aortic aneurysm (aaa) measurement at index was only 35mm and should be >50mm.The final patient status was reported to be stable pending further 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 afx2.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal and an ovation ix iliac limb.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.Reportedly, at the initial procedure, the patient had a right common iliac aneurysm and the physician elected to land on th left in order to spare the left internal.Approximately four (4) years post initial procedure, routine follow-up identified a type ib endoleak in the left common iliac artery with the aneurysm at 25mm.Reintervention has been scheduled.The patient is reported to be stable.After the follow-up one report, reintervention was completed with the implant of an ovation ix extender, extending to the left internal and not crossing.The procedure was successful and the patient is doing well.
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 the device remains implanted.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 complaint is confirmed.The type ib endoleak with aneurysm enlargement remains unconfirmed.This is moderately consistent with the reported adverse event/incident.Device, user, or procedure relatedness of this adverse event/incident could not be determined with the medical records available for review.Definitive anatomy relatedness could not be determined; however, there was bilateral iliac aneurysms at index, maximum right 3.8cm left 2.8cm.This could have contributed to the reported type ib endoleak with aneurysm enlargement.Though, the distal diameters measured on label (right 12mm and left 19mm).The rate of left iliac sac growth from 09/07/2018 to 08/19/2022 was 2.9mm.During the investigation, endologix found reasonable evidence to suggest the device was used off-label as the abdominal aortic aneurysm (aaa) measurement at index was only 35mm and should be >50mm.The final patient status was reported as discharged home on postoperative day one 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.B2: outcomes attributed to ae - updated, b5: describe event or problem ¿ updated, b6: relevant tests and lab data ¿ updated, b7: relevant tests and lab data - updated, g3: awareness date ¿ updated, h6: health effect - impact code ¿ remove 4614.

• 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: 15328839
• Report Number: 2031527-2022-00215
• Device Sequence Number: 5375312
• Product Code: MIH
• UDI-Device Identifier: 00818009014412
• UDI-Public: (01)00818009014412(17)190613
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2022

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: 06/13/2019
• Device Model Number: BEA28-80/I20-40
• Device Lot Number: 1948555-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 07/05/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/02/2022; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 1752681003); OVATION IX ILIAC LIMB (LN FS042318-35)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male