MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/07/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will 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 initially treated for an abdominal aortic aneurysm (aaa) with the implantation of an afx bifurcated stent graft and an afx vela infrarenal on (b)(6) 2024.During the procedure, it was noted that the afx vela infrarenal required repositioning, which necessitated the removal of the entire sheath.As the vela could not be re-sheathed before insertion into the aorta, a secondary afx vela infrarenal was used.The patient was reported to be recovering well post-procedure.It was reported that the family withdrew care for an unknown reason and the patient passed away on (b)(6) 2024.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in accordance with endologix operating procedures and work instructions.Whenever possible, endologix makes at least three good-faith efforts to retrieve the device associated with the reported adverse event/incident, as well as relevant medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination necessary for device identification confirmed that the device was properly manufactured and released in accordance with the device master record.This review confirms that there were no manufacturing or processing non-conformities identified that would have contributed to the reported adverse event/incident.An evaluation of the returned device was also completed.Endologix received one (1) vela proximal endograft system, with the stent included.The device was shipped in a box and double-bagged.Upon receipt, blood and tissue residue were present.The device was decontaminated, and a visual inspection was performed.The vela proximal endograft system exhibited minimal kinking throughout.The stent graft was successfully deployed; however, kinks and in-folding observed on the sheath suggest that there may have been resistance during the advancement or removal of the system.Endologix was unable to replicate the reported issue.The root cause of the damage remains undetermined.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix indicates that the afx device is difficult to separate (demate), unable to advance, and unable to deploy; however, these complaints are unconfirmed.The death complaint is confirmed and is moderately consistent with the reported adverse event/incident.The complaint is likely user-related.The procedure was complex, involving the placement of eleven stents beginning in the thoracic aorta and ending in the iliac arteries; all but two of the grafts were non-endologix.Retroperitoneal hematomas were noted postoperatively during the diagnostic laparotomy performed on (b)(6) 2024, in the area of the supraceliac aorta and right perinephric area, where non-endologix stents were placed.The treatment of a concomitant thoracoabdominal aneurysm carries cautionary product usage.Procedure-related harms include renal insufficiency (requiring dialysis), retroperitoneal hematomas, abnormal blood loss (hematomas, hemorrhagic ascites, disseminated intravascular coagulation [dic]), hemodynamic instability, additional surgical procedures, and death.The patient's death was determined to be procedure-related.The final patient status was reported as deceased on (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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• 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: 19624577
• Report Number: 3011063223-2024-00095
• Device Sequence Number: 17726008
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)241015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2024
• Device Model Number: A34-34/C100V
• Device Lot Number: 2517260-007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL LOT # 2532296009; AFX2 BIFURCATED STENT GRAFT LOT# 2763611008
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Female