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

Model Number TV-AB2680-I

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Paralysis (1997)

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 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.On (b)(6) 2018 it was reported to endologix that the patient remained unstable post implant, and presented with a right limb thrombosis, spinal cord and gut infarction, and paralysis 3 days post-op.A thrombolysis re-intervention was completed; however, the patient subsequently expired 4 days post-op.

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.As such, device, user, procedure or anatomy relatedness of this complaint could not be determined.The delivery system was not available for evaluation and the stent graft remains implanted.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.The post procedural thrombosis, and subsequent endovascular thrombolysis of the right iliac limb (reference 3008011247-2018-00133) was most likely user related.The spinal cord and mesenteric cord infarct, paralysis and death and cause of death could not be confirmed and therefore device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported to be expired four days post implant, and one day post an endovascular repair for the occlusion.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: 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: 7567456
• MDR Text Key: 110027317
• Report Number: 3008011247-2018-00119
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680I1
• UDI-Public: +M701TVAB2680I1/$$3200829FS08181733G
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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: 08/29/2020
• Device Model Number: TV-AB2680-I
• Device Lot Number: FS081817-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 84 YR