MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I20-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/01/2022
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 afx with duraply.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately seven (7) years post initial procedure, a type 3a endoleak with junctional separation and aneurysm enlargement was identified after the patent underwent a computed tomography (ct) scan.A re-intervention was done, and the physician elected to implant (2) two afx vela infrarenals.It was confirmed that the endoleak was resolved, and the final patient status was reported as being 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 iiia endoleak with complete component separation, sac growth of 21mm, and an additional endovascular procedure confirmed.These findings are consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (non-device related) from the lumbar artery was discovered during an emergent visit due to gastrointestinal bleeding on 03/27/2019.The clinical assessment also determined an endovascular repair occurred on 06/11/2020 post motor vehicle accident.These findings were discovered during an examination of discharge summaries.The most likely causation for the type iiia endoleak with complete component separation and sac growth of 21mm is anatomy-related due to the aortic angle increasing from 20 degrees to 65 degrees (aortic remodeling).There were no procedure-related harms identified.It was not clear what type of endovascular repair occurred on 06/11/2020.It may have been for the previously discovered type ii endoleak of the lumbar artery, but that could not be conclusively determined.The final patient status was reported to be discharged on the first postoperative day 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 afx with duraply.B5: describe event or problem - updated g3: awareness date ¿ updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately seven (7) years post initial procedure, a type 3a endoleak with junctional separation and aneurysm enlargement was identified after the patent underwent a computed tomography (ct) scan.A re-intervention was done, and the physician elected to implant (2) two afx vela infrarenals.It was confirmed that the endoleak was resolved, and the final patient status was reported as being stable.After the initial report, the clinical assessment determined that there was evidence to reasonably suggest a type ii endoleak (non-device related) from the lumbar artery was discovered on (b)(6) 2019.The clinical assessment also determined that an endovascular repair occurred on (b)(6) 2020 post motor vehicle accident.The repair and type ii endoleaks were discovered during a review of the medical records.

• Brand Name: AFX
• 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: 15086059
• Report Number: 2031527-2022-00193
• Device Sequence Number: 5161547
• Product Code: MIH
• UDI-Device Identifier: 00818009012623
• UDI-Public: (01)00818009012623(17)171217
• 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: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 12/17/2017
• Device Model Number: BA28-70/I20-30
• Device Lot Number: 1251891-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL 1252463015
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male