MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-90/I16-30

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504); Malposition of Device (2616); Device-Device Incompatibility (2919)

Event Date 03/18/2024

Event Type  Injury  

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 Description

The patient was being treated for an endovascular aneurysm repair (evar) on (b)(6) 2024.The afx2 bifurcated stent graft (bsg) and afx vela suprarenal were implanted from right access.Angiography showed a possible type iiib endoleak.The physician elected to implant a second afx2 bsg.The second afx2 bsg was not tightly sit on the terminal aorta, and the distal edge of afx2 bsg left limb appeared to not be completely expanded.Angiography showed a type iiib endoleak through the first afx2.Balloon touch-up did not resolve this problem.The physician decided to add an afx limb on the left common iliac artery.A becton dickinson e-luminexx (non-endologix) stent was then added inside the afx limb; however, the type iiib endoleak was still slightly observed.The operation was finished.Patient status was not provided.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.

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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows type iiib endoleak (unresolved) is unconfirmed.The malposition of the main body complaint is confirmed.The additional endovascular procedure (addition of a second main body) complaint is confirmed.This is moderately consistent with the reported adverse event/incident.It is unclear if the reported endoleak is a type iiib endoleak vs a type ii endoleak.The contrast filling the sac in the distal main body appeared delayed and a possible type ii endoleak was seen at the same time as the filling of the sac.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final patient status was not reported.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 - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Type of Device: 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: 19053714
• MDR Text Key: 339555006
• Report Number: 3011063223-2024-00051
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)261028
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2730123019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX LIMB (LN 2532190003); AFX VELA SUPRARENAL (LN 2699188013); AFX2 BIFURCATED STENT GRAFT (LN 2699188013); BECTON DICKINSON LUMINEXX (LN UNK)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male