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

Model Number TV-IL1414120-I

Device Problems Collapse (1099); Use of Device Problem (1670)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 11/17/2022

Event Type  Injury  

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the alto abdominal stent graft system.Two (2) days post-initial procedure, the patient was suffering from left leg pain, and their leg felt cold.A computerized tomography scan identified that the left limb was thrombosed and collapsed.Reintervention was completed with the implant of two (2) medtronic limbs higher than the bifurcation.The final patient status was reported to be critical; however, stable.

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 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.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 adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the ovation ix iliac limb occlusion, collapsed stent (left iliac limb) and additional endovascular procedure are confirmed.This is consistent with the reported event.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Though a definitive root cause cannot be determined, the conicity of the neck measured off label at 25% and the first 1/2 ring of the iliac limbs were in the 46-degree infrarenal angulation.It is unclear if either of these factors contributed to the event.The final patient status was reported to be critical but stable.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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• 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: 15937646
• MDR Text Key: 305046612
• Report Number: 3008011247-2022-00160
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370640
• UDI-Public: (01)00850007370640(17)250808(10)FS080522-59
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TV-IL1414120-I
• Device Lot Number: FS080522-59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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 FS060322-37); OVATION IX ILIAC LIMB (LN FS062722-63); OVATION PRIME FILL POLYMER (FF041222-01)
• Patient Outcome(s): Required Intervention