MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the 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 underwent an endovascular aneurysm repair (evar) on (b)(6) 2022 with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, two (2)excluder legs, and a liminexx stent.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.Approximately one year post initial procedure the aneurysm had grown from 51mm to 56mm.Approximately 1.5 years post initial procedure, during a routine follow-up with computed tomography (ct) and intraoperative angiography, the aneurysm measured 62mm which the physician suspects is due to a type iiib endoleak.Reintervention is scheduled to be on (b)(6) 2024.
Event or Problem Description
The patient underwent an endovascular aneurysm repair (evar) on (b)(6) 2022 with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, two (2)excluder legs, and a liminexx stent.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.Approximately one year post initial procedure the aneurysm had grown from 51mm to 56mm.Approximately 1.5 years post initial procedure, during a routine follow-up with computed tomography (ct) identified that the aneurysm measured 62mm and a possible type iiib endoleak.The re-operation was performed on (b)(6) 2024.On angiography aneurysm was show to continue to grow and endoleak was not confirmed.The physician elected to reline afx2 bifurcated stent graft with or excluder conformable system.Patient status is unknown.
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 it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix the aneurysm enlargement, possible type iiib endoleak and additional endovascular procedure complaints are unconfirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.There was concomitant product use, it is unclear if this contributed to the reported event.The final patient status was reported to be post additional endovascular procedure done (b)(6) 2024.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 corrections: g3- awareness date: updated h6- investigation finding codes: removed 3233 h6- investigation conclusion codes: removed 11.

• 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: 19035163
• Report Number: 3011063223-2024-00043
• Device Sequence Number: 7042167
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)250315
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 03/15/2025
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 2558258007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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 SUPRARENAL, LOT # 2556692011; EXCLUDER LEG (NON-ENDOLOGIX) LN UNK; EXCLUDER LEG (NON-ENDOLOGIX) LN UNK; LIMINEXX STENT (NON-ENDOLOGIX) LN UNK
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Male