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

Model Number	TV-IL1418140-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the ovation ix, left common iliac artery occlusion, left limb ischemia, and additional surgical procedures are confirmed.The malposition of the device (alto graft 5mm below right renal artery) and renal insufficiency complaints are also confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely procedure and anatomy-related.The aortic body landed 5mm below the right renal artery, creating a type ia endoleak.A (non-endologix) excluder cuff (gore) was deployed proximally, encroaching on the right renal artery.This likely caused hypoperfusion of the right kidney, contributing to the renal insufficiency (procedure-related).The common iliac arteries were tortuous and severely calcified.It was noted on the operative note dated february 27, 2024, that there was a report of an acute or chronic disease with heavily calcified plaque, likely contributing to the left limb occlusion (anatomy-related).The index procedure created an acute thrombus, adding to the chronic disease (procedure-related).Procedure-related harms are hemodynamic instability.The final patient status is reported as hospitalized on postoperative day four with a recommendation for rehabilitation at discharge.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.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2024.It was reported that the procedure was challenging due to angulation and a short neck.Despite these obstacles, the physician managed to implant the alto stent graft and perform balloon dilation 16 minutes after polymer mixing.Both limbs were positioned without difficulty.Following the implantation, there was a notable aggressive type ia endoleak.To address this, a (non-endologix) palmaz p4010 with a new coda balloon was introduced, but the ia endoleak persisted at a reduced rate.Additional attempts with a q50 balloon and zmed 25x40 balloon were unsuccessful in completely halting the ia endoleak.As a final measure, a (non-endologix) gore excluder extension was deployed, resulting in a significant reduction in the ia endoleak reported under mfr# 3008011247-2024-00018.On february 27, 2024, the patient presented to the emergency room with bilateral leg pain.It was reported that the left lower extremity appeared cold, pale, and mottled from the knee downwards with an absent distal pulse.The left common iliac artery (lcia) was occluded, and there was partial occlusion of the common femoral artery (cfa).The superficial femoral artery (sfa) showed reconstitution, and the popliteal artery was also occluded with no contrast visualization distally below the popliteal artery.The physician elected to perform a right-to-left femoral-femoral artery bypass.During the procedure, a significant calcified plaque was observed.The left limb profunda, superficial femoral artery (sfa), and common femoral artery (cfa) were subjected to an endarterectomy.A thrombectomy of the left lower extremity (lle) was done, addressing both chronic and acute thrombus.Adequate revascularization was successfully attained, and a four-compartment fasciotomy was performed on the left lower extremity.The final patient status was reported as discharged home on postoperative day two.

• 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: 19241824
• Report Number: 3008011247-2024-00048
• Device Sequence Number: 12622382
• Product Code: MIH
• UDI-Device Identifier: 00850007370305
• UDI-Public: (01)00850007370305(17)260510(10)FS050923-11
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• 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
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2026
• Device Model Number: TV-IL1418140-J
• Device Lot Number: FS050923-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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: (NON-ENDOLOGIX) CORDIS; (NON-ENDOLOGIX) GORE; ALTO MAIN BODY FS101823-29; OVATION IX ILIAC LIMB FS080123-15; OVATION PRIME FILL POLYMER FF041823-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male