MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.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.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately one (1) day after the initial procedure, the patient exhibited symptoms of back pain and experienced a stoppage of urine output.In response, a computerized tomography (ct) scan was performed, revealing proper blood flow to the renal area.However, later on, the same day, it was reported that the patient required a surgical conversion, during which the afx vela suprarenal device was explanted.Unfortunately, no further details have been provided regarding the current status of the patient's surgical conversion.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately one (1) day after the initial procedure, the patient exhibited symptoms of back pain and experienced a stoppage of urine output.In response, a computerized tomography (ct) scan was performed, revealing proper blood flow to the renal area.However, later on, the same day, it was reported that the patient required a surgical conversion, during which the afx vela suprarenal device was explanted.Unfortunately, no further details have been provided regarding the current status of the patient's surgical conversion.Clarification: the patient experienced renal occlusion at time of event.Additional information: a clinical assessment identified an additional endovascular procedure also occurred.This procedure involved placing a fenestrated graft on (b)(6) 2023.The finding for this supplementary intervention was based on a thorough review of the operative report and discharge summary.A separate report will be filed for this tertiary intervention event (reference patient id (b)(6)).
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 shows that the afx, surgical conversion, explant of the proximal extension, and renal occlusion are confirmed.This is consistent with the reported adverse event/incident.The device, user, procedure, or anatomy-relatedness of this complaint could not be determined.The procedure-related harms were hemoperitoneum (retroperitoneal bleed), respiratory insufficiency (the patient was still intubated on (b)(6) 2023), and cephalad graft migration.The clinical evaluation also shows reasonable evidence to suggest that an additional endovascular procedure (fenestrated graft was done on (b)(6) 2023) also occurred.The additional endovascular procedure was discovered on (b)(6) 2023, during a review of the operative report and the discharge summary.The cephalad graft migration caused the renal occlusion.The surgical conversion with an explant of the proximal extension on (b)(6) 2023 was done to repair the renal occlusion.It is unclear why the cephalad graft migration occurred.The final patient status was reported as discharged on 07/15/2023.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.B5: describe event or problem ¿ updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Additional Manufacturer Narrative
H6: health effect - clinical code - 2119 additional h6: health effect - impact code - 4619 additional h6: investigation finding codes - 4247 removed.

• 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: 17347567
• Report Number: 2031527-2023-00189
• Device Sequence Number: 12272503
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)260214
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/29/2023

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: 02/14/2026
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 2653732-005
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 09/18/2023; Not provided
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/18/2023; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: AFX2 BIFURCATED STENT GRAFT (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male