MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft, an afx vela suprarenal, and two (2) afx limb stent graft.The afx2 bifurcated stent graft and an afx vela suprarenal were deployed.During the advancement of an afx limb stent graft, the afx vela suprarenal was pushed proximal over the renals while trying to re-advance the sheath to place the afx limb stent graft.An attempt to pull the afx limb stent graft down was made; however, it was unsuccessful.The physician elected to surgically open the aorta, explanted the afx vela suprarenal, placed an open graft (non-endologix) under the renals, and sewed the distal part of the open graft to the top of the afx2 bifurcated stent graft.Post-procedure the implanted devices became occluded.The patient underwent aortobifemoral bypass.The patient was on a ventilator; however, stable.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.The explanted device was discarded by the hospital, and the other devices 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.An evaluation of the device could not be completed.The explanted device was discarded by the hospital, and the other devices remain 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 the malposition of the proximal extension is unconfirmed.The renal occlusion, aorto-iliac occlusion and surgical conversion (aorto-bifemoral bypass) are confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the renal occlusion, aorto-iliac occlusion and surgical conversion (aorto-bifemoral bypass) is user related.The procedure related harms identified were a left pneumoperitoneum, mesenteric ischemia, an ileus and acute kidney injury.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The iliac diameters were off label (right 27.1mm and left 41.2mm) should be 10-23mm.There was no abdominal aortic aneurysm as the largest diameter was 3.3cm.The bilateral access sites were off label (right 3.9mm and left 3.6mm) should be greater than or equal to 6.5mm.The final patient status remains unknown.The final patient status was not made available to endologix.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.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• 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: 13891708
• Report Number: 2031527-2022-00063
• Device Sequence Number: 6328547
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)230616
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 06/16/2023
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 2362780006
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT (LN 2243884012); AFX LIMB STENT GRAFT (LN 2346456006); AFX2 BIFURCATED STENT GRAFT (LN 2389798005)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male