MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for a saccular abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft.At the end of the procedure a type ii endoleak (non-device related) remained.Approximately six (6) months post initial procedure reintervention was being performed to treat the type ii endoleak; however, aneurysm enlargement of 56mm with a type ia endoleak was identified.The physician elected to treat the type ia endoleak with implant of an afx vela suprarenal extension.The type ii endoleak from the ima was mild and remaining.Patient status post-reintervention was not provided.
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.
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.A clinical evaluation of the adverse event/incident could not be completed.The type ia endoleak, type ii endoleak, aneurysm enlargement and additional endovascular procedure are unconfirmed.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.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 post-reintervention was not provided.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: b5: describe event or problem - updated.G3: date received by manufacturer - 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 a saccular abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft.At the end of the procedure a type ii endoleak (non-device related) remained.Approximately six (6) months post initial procedure reintervention was being performed to treat the type ii endoleak; however, aneurysm enlargement of 56mm with a type ia endoleak was identified.The physician elected to treat the type ia endoleak with implant of an afx vela suprarenal extension.The type ii endoleak from the ima was mild and remaining.Patient status post-reintervention was not provided.Note: this patient has another reported event for an aorto-duodenal fistula, open repair, patient expired.This was reported under manufacturer report number 2031527-2021-00497.

• 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: 12962821
• Report Number: 2031527-2021-00484
• Device Sequence Number: 13885250
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)191018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2021

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: 10/18/2019
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1600614-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female