MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR, INC) OVATION IX; MAIN BODY

Model Number TV-AB2080-J

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Necrosis (1971); Pain (1994); Rash (2033)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied indicating a potential intravascular leak of polymer, and the patient experienced hypotension.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.The aneurysm was successfully excluded at the conclusion of the implant procedure.Two days post-op, the patient developed a large area of skin injury and skin discoloration on the flank of the back, with an elevated cpk.The area of skin injury and discoloration progressed to skin necrosis and an open skin wound, in addition to fat necrosis in the area of injury and a congealing of fat into a moveable ball-like structure on the flank.The patient has persistent pain in the area of skin injury.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

Manufacturer Narrative

The root cause for the emptying of the polymer syringe and intravascular leak of polymer could not be definitively confirmed with the information available.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6)2018, (b)(6)2018, (b)(6)2018 and denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Based on the description of the event, it was noted that the device initially landed low and was advanced proximal 1.5cm up to the intended landing zone which may have contributed to the event.Based on a review of the returned delivery system, the delivery system fill tube and guidewire lumen was observed to be kinked.It is possible that the kinking could have occurred during repositioning of the delivery system proximal 1.5cm, compromising the junction of the delivery system fill tube to stent graft; however, this cannot be definitively confirmed without a review of the intraoperative imaging.All other delivery system components appeared intact with no evidence of damage.A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.Based on similar reported events, the most likely cause of the emptying of the polymer syringe and intravascular leak of polymer was likely due to a compromise in the integrity of the aortic body stent graft fill channels and/or mating junction of the delivery system to the stent graft; however, this could not be definitively confirmed.A field safety notice (fs-0009) was released on (b)(6)2018 to communicate the risk of polymer leak events with the ovation device under circumstances in which the device is not used in accordance with the device instructions for use.New codes: method: 4109, 4112, 3331.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR, INC); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7631987
• MDR Text Key: 112139128
• Report Number: 3008011247-2018-00145
• Device Sequence Number: 1
• Product Code: MIH
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS020118-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILL POLYMER-FF120517-01.; ILIAC LIMB-FS040518-53, FS030718-81.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR