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

Model Number TV-IL1412160-I

Device Problems Collapse (1099); Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/18/2023

Event Type  Injury  

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system.Twenty-six days post-implant left limb thrombosis was identified at a routine follow-up visit.It was also found that the proximal end of the iliac limbs were placed in an angulated section of the aneurysm sac.This made one limb higher than the other so this may have compromised flow to the lower limb.Also due to the angulated aorta, the lower limb is slightly crushed and is smaller in diameter.This may have compromised flow and be the cause of the significant thrombus burden in the left limb.Reportedly, reintervention is planned was planned for (b)(6) 2023, with the implant of a non-endologix device; however, confirmation has not yet been received.

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.

Manufacturer Narrative

The reported 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 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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device remains implanted.A clinical evaluation of the incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported ovation left iliac limb buckling (crushed limb) and left iliac limb thrombosis (stenosis) are confirmed.This is consistent with the reported incident.The most likely causation for the reported event is anatomy related due to the proximal end of the iliac limb being placed in an angulated (89-degree inner angulation) section of the aneurysm sac.Additionally, the right iliac limb was placed 4mm above the left limb, this also likely contributed to the reported incident.Procedure related harms for this incident could not be determined.The final patient status was reported as stable and waiting reintervention.No additional investigation of this reported 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 incidents.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

Manufacturer Narrative

Correction; h6: investigation finding codes - remove 4247.

• 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: 16312744
• MDR Text Key: 308949874
• Report Number: 3008011247-2023-00013
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370619
• UDI-Public: (01)00850007370619(17)250524(10)FS052322-12
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TV-IL1412160-I
• Device Lot Number: FS052322-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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 FS062422-18); OVATION IX ILIAC LIMB (LN FS022422-24); OVATION PRIME FILL POLYMER (LN FF092222-03)
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR