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

Model Number TV-IL1422120-J

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient; therefore, it will not be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with the ovation ix abdominal stent graft system and two (2) ovation ix iliac limbs to treat an abdominal aortic aneurysm (aaa).Reportedly, at implant, the limbs were crossed.Approximately four (4) years post initial procedure the right ovation ix iliac limb had slipped out of the ovation ix main body.Successful reintervention was completed with cannulation of the main body by implanting an ovation ix iliac limb bridging the main body to the iliac limb that slipped out.Final patient status was reported to be discharged on day post re-intervention and fine.Patient will continue to be monitored.

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.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 malposition and right limb stent movement of 5mm, component separation (aortic body and right limb stent) event/incident were confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the right limb stent movement user related due to the malposition of this stent at the initial implant procedure.The right stent was placed 8mm below the left stent.This resulted in the right limb stent and aortic body separation.The final patient status was reported as being stable post the secondary endovascular procedure.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.

• Brand Name: OVATION IX
• Type of Device: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10950380
• MDR Text Key: 219863670
• Report Number: 3008011247-2020-00139
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120J1
• UDI-Public: +M701TVIL1422120J1/$$3190510FS02061626I
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2019
• Device Model Number: TV-IL1422120-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS020616-26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS092915-18); OVATION IX MAIN BODY (LN FS021616-23); OVATION PRIME FILL POLYMER (LN FF031216-02)
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR