MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/23/2023
Type of Reportable Event	Death
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.H3 other text : device remains implanted.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix extender.This procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately three (3) years post-initial procedure, the patient was in a car accident experiencing internal trauma.A possible type 3b endoleak was identified.Reintervention was completed with implant of an afx2 bifurcated stent graft, an afx vela infrarenal, and two (2) ovation ix extender.The type 3b endoleak was reported to be sealed.Reference mfr.Report # 2031527-2022-00124.Now, approximately one (1) year post-reintervention, the patient has been in a car accident and there is a possible type 3b endoleak.Reintervention has been scheduled.
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 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.Due to the absence of medical records and medical imaging device, use, procedure, and/or anatomy relatedness to this incident could not be evaluated.The final patient status was reported to be death due to complications related to the car accident; however, endologix was unable to confirm this as medical records nor imaging were 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 incidents.Device iteration is afx2.
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.Corrections: b2: outcomes attributed to ae - updated.B5: describe event or problem - updated.G3: awareness date - updated.H1: type of reportable event - updated.H6: health effect - impact code - remove 4614.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix extender.This procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately three (3) years post-initial procedure, the patient was in a car accident experiencing internal trauma.A possible type 3b endoleak was identified.Reintervention was completed with implant of an afx2 bifurcated stent graft, an afx vela infrarenal, and two (2) ovation ix extender.The type 3b endoleak was reported to be sealed.Reference mfr.Report # 2031527-2022-00124.Now, approximately one (1) year post-reintervention, the patient has been in a car accident and there is a possible type 3b endoleak.Reintervention has been scheduled.After the initial report, additional information was received that the reintervention was cancelled as the patient passed away on an unknown date due to complications from the car accident.

• 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: 16934924
• Report Number: 2031527-2023-00071
• Device Sequence Number: 17684762
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)240806
• 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: 2022
• 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,Followup
• Report Date (Section B): 04/24/2023

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: 08/06/2024
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 2496063010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 06/13/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/07/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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 VELA INFRARENAL (LN 2494729004); AFX VELA SUPRARENAL (LN 1820520004); AFX2 BIFURCATED STENT GRAFT (LN 1984019-009); OVATION IX EXTENDER (LN FS052418-46); OVATION IX EXTENDER (LN FS111521-24); OVATION IX EXTENDER (LN FS111721-47)
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 78 YR
• Patient Sex: Male