MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1410140-J
Medical Device Problem Codes	Off-Label Use (1494); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	04/24/2023
Type of Reportable Event	Death
Additional 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.H3 other text : devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa).It was noted that patient also had aortic occlusive disease and heavily calcified iliac arteries (cautionary product use).The physician intended to use the alto abdominal aortic aneurysm stent system for aui (aorto-uni iliac) with femoral-femoral crossover bypass.During the initial implant procedure, the physician was unable to advance the alto stent graft past the iliac bifurcation, and therefore elected to use an ovation ix iliac limb to create the aui.The ovation ix device was implanted in the aorta, extending down the right iliac artery.No sign of complications were noted at this time of the procedure.The physician then proceeded by implanting a gore (non-endologix) vbx stent in the proximal aorta above the ovation ix iliac limb.A couple of minutes later, the patient's blood pressure dropped (classified as hypotension) and a hole in the aorta was diagnosed.Several contrast injections were made and the bleeding was noted to be originating from the proximal aorta.After several attempts to control the bleeding, the physician converted the patient to open repair.The patient ultimately passed away a couple hours later.No additional information is currently available regarding this initial report.
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.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 shows the reported ovation ix, perforation of the aorta (reported as hole in the aorta), hemodynamic instability (reported as hypotension) and death are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to the following contributing factors: absence of an abdominal aortic aneurysm, thickened calcifications throughout the aorta and iliacs (aortoiliac occlusive disease), preoperative occlusion of the distal aorta 3cm above the bifurcation and extending into the bilateral iliacs, and concomitant product use of a non-endologix stent and ovation limb in the aorta.The most likely causation for the patient death is procedure-related.Procedure-related harms include abnormal blood loss, cardiac arrest and surgical conversion.The final patient status was reported as deceased.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.Corrections: h6 medical device probem codes; remove 3190, h6 investigation finding codes; remove 3233, h6 investigation conclusion codes; remove 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 16947227
• Report Number: 3008011247-2023-00058
• Device Sequence Number: 12356530
• Product Code: MIH
• UDI-Device Identifier: 00850007370145
• UDI-Public: (01)00850007370145(17)250810(10)FS080922-53
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 04/24/2023

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: 08/10/2025
• Device Model Number: TV-IL1410140-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS080922-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GORE (NON-ENDOLOGIX) VBX STENT.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Unknown