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

Model Number TV-IL1418140-J

Device Problems Complete Blockage (1094); Deformation Due to Compressive Stress (2889); Insufficient Information (3190)

Patient Problems Paralysis (1997); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 08/23/2023

Event Type  Injury  

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 Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one and a half (1.5) years post initial procedure, the patient presented at routine follow-up with a thromboembolism from the right limb to the right common iliac artery as detected per ct (computed tomography) scan.Reportedly, the patient has been unable to move his leg since one (1) month post initial implant, but it is unknown if the patient had any follow-ups prior to the (b)(6) 2023 exam due to the implanting physician leaving tokushima university hospital in (b)(6) 2023.(b)(6) will discuss a future treatment plan with the patient involving a femoral-femoral bypass.

Manufacturer Narrative

The reported 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 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 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 reported thromboembolism of the right ovation ix limb was found to be a right common iliac artery occlusion (causing thrombus formation).There was no evidence of an additional endovascular intervention.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest proximal right iliac stent buckling occurred.The buckling was discovered during a review of the computed tomography (ct) scan dated 08/21/2023.The complaint is most likely anatomy related.The neck length was long at 65 mm.The two 14 mm limbs landed in a p2+40 diameter of 19.1mm causing the stent to buckle.The stent buckling likely caused the right common iliac limb occlusion.The occlusion caused thrombus formation.Procedure-related harm for this complaint cannot be determined.The final patient status is not reported; however, the physician is planning a future intervention with a femoral-to-femoral bypass.No additional investigation of this reported 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 events/incidents.Corrections: b5 describe event or problem, g3 awareness date, h6 health effect - clinical code ; remove 4440, h6 investigation finding codes; remove 3233, h6 investigation conclusion codes; remove 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one and a half (1.5) years post initial procedure, the patient presented at routine follow-up with a thromboembolism from the right limb to the right common iliac artery as detected per ct (computed tomography) scan.Reportedly, the patient has been unable to move his leg since one (1) month post initial implant, but it is unknown if the patient had any follow-ups prior to the (b)(6) 2023 exam due to the implanting physician leaving tokushima university hospital in (b)(6) 2023.Dr.Yamamoto will discuss a future treatment plan with the patient involving a femoral-femoral bypass.Additional information: clinical assessment determined that the reported thromboembolism affecting the right ovation ix limb has been identified as a right common iliac artery occlusion, resulting in thrombus formation.The clinical assessment also determined proximal right iliac stent buckling occurred that was not in the event as reported.The buckling was discovered during a review of the computed tomography scan dated (b)(6) 2023.

• Brand Name: OVATION IX
• Type of Device: 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: 17773074
• MDR Text Key: 323720406
• Report Number: 3008011247-2023-00166
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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
• Device Operator: Health Professional
• Device Model Number: TV-IL1418140-J
• Device Lot Number: FS031622-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTO MAIN BODY, LN FS042822-53; OVATION IX ILIAC LIMB, LN FS031622-51; OVATION PRIME POLYMER FILL, LN FF021522-01
• Patient Outcome(s): Other
• Patient Sex: Male