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

Model Number TV-AB2680-J

Device Problems Kinked (1339); Leak/Splash (1354); Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Rupture (2208); Stenosis (2263); Blood Loss (2597)

Event Date 01/23/2018

Event Type  Injury  

Event Description

The clinical assessment for this event discovered additional adverse events which include inability to cannulate the contralateral gate, inadequate stent graft patency, proximal loss of seal, and distal loss of seal.Based on the clinical assessment for this event, the most likely cause of the inability to advance the aortic body was determined to be anatomy related.The most likely cause of the inability to cannulate the contralateral gate and intraoperative inadequate stent graft patency was found to also be anatomy related.The most likely cause of the proximal loss of seal was unable to be determined with the given information.The most likely cause of the distal loss of seal was found to be user related due to the incomplete sealing of the lcia post non endologix vascular plugs.Procedure related harms included ileus, acute renal and respiratory failure with related cardiopulmonary arrest, persistent metabolic encephalopathy, aspiration pneumonia, tension pneumothorax and chest tube insertion, persistent endoleak three days post implant.The patient was discharged on the seventeenth post operative day to a skilled nursing facility in fair condition and no additional patient sequelae has been reported.

• 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 (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 7496956
• MDR Text Key: 107684441
• Report Number: 3008011247-2018-00090
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Report Date: 04/16/2018

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: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS120417-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR