MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	02/09/2023
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.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal and an afx limb stent graft.Approximately three (3) years post initial procedure, a type i or type 3 endoleak was identified at a routine follow up.Reintervention was completed with the implant of an afx vela suprarenal and an afx vela infrarenal (reported under mfr#3008011247-2020-00057).Now, approximately three (3) years post-secondary, a possible type 3b endoleak with aneurysm enlargement has been identified.A tertiary has been scheduled for (b)(6) 2023.Patient is reportedly stable.
Additional Manufacturer Narrative
The reported 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 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 incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement and type iiib endoleak complaints are unconfirmed.The additional endovascular procedure (tertiary) complaint is confirmed.This is moderately consistent with the reported incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint could be determined.The final patient status was reported as discharged home on postoperative day two in stable condition.No additional investigation of this reported 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 incidents.Device iteration is afx2.B2: outcomes attributed to adverse event ¿ updated.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: health effect - impact code ¿ remove code 4614.H6: health effect - impact code ¿ remove code 4065.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 afx2 bifurcated stent graft, an afx vela suprarenal and an afx limb stent graft.Approximately three (3) years post initial procedure, a type i or type 3 endoleak was identified at a routine follow up.Reintervention was completed with the implant of an afx vela suprarenal and an afx vela infrarenal (reported under mfr#: 3008011247-2020-00057).Now, approximately three (3) years post-secondary, a possible type 3b endoleak with aneurysm enlargement has been identified.A tertiary has been scheduled for on (b)(6) 2023.Patient is reportedly stable.After the initial report, additional information was provided reporting that reintervention was completed with the implant of an afx2 bifurcated stent graft and an afx vela infrarenal on (b)(6) 2023.It was confirmed at reintervention that the endoleak was a type 3b.Patient was reported to be doing well post-reintervention.

• 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: 16454267
• Report Number: 2031527-2023-00035
• Device Sequence Number: 5599961
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)171205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 12/05/2017
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 1623185R014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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
• 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 LIMB STENT GRAFT (LN 1343298007).; AFX VELA INFRARENAL (LN 2315526R005).; AFX VELA SUPRARENAL (LN 1678694018).; AFX VELA SUPRARENAL (LN 2338925005).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Male