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

Model Number TV-AB2680-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)

Event Date 05/09/2018

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.The aortic body stent graft was positioned and deployed as expected.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied.Another polymer kit was mixed and attached to the delivery system; however, the second polymer syringe also 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.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; pre-operative and/or post-operative imaging were not available for review.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.It was noted that forward pressure was used to manipulate the delivery system (<90°) during polymer fill, and the crossover lumen was used pre-injection of the fill polymer which is outside the procedural steps in the device instructions for use (ifu).The delivery system was not available for evaluation and the stent graft remains implanted.As of the date of this report, there have been additional patient sequelae reported.A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: OVATION IX
• Type of Device: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 7587345
• MDR Text Key: 110627111
• Report Number: 3008011247-2018-00117
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3210402FS022418810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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: 04/02/2021
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS022418-81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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: FILL POLYMER - FF021318-02, FF021218-01; ILIAC LIMBS - FS082917-20, FS042517-20; ILLIAC LIMBS - FS110816-33
• Patient Outcome(s): Required Intervention