MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number TV-AB2380-I

Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm in 2017.At the one year follow up, it was noted that the patient had an increase in aneurysm size.Patient is currently being monitored, plans for reintervention has not been reported.As of this report, no additional patient sequelae has been reported.

Manufacturer Narrative

Clinical assessment was performed based off the provided medical records.The aneurysm enlargement was confirmed.Devices remain implanted in the patient; therefore, a device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device codes - 1031 removed; correction.Method codes - 3263 and 3323 removed; correction.Results codes - 3221 removed; correction.Conclusion codes - 92 removed; correction.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7653167
• MDR Text Key: 112837841
• Report Number: 3008011247-2018-00149
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380I1
• UDI-Public: +M701TVAB2380I1/$$3191028FS061516225
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: TV-AB2380-I
• Device Lot Number: FS061516-22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION LIMB-LOT: FS041316-47; OVATION LIMB-LOT: FS041816-32
• Patient Outcome(s): Other