MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

A device lot number was not provided; therefore, an investigation was unable to be performed and a cause of the reported event was unable to be determined.Green, michael s., ahmed, brittany, bourm, kelsey, coffey, charles, salyers, william.Septic thrombus of a transjugular intrahepatic portosystemic shunt (tips) resulting in psoas muscle abscess: a case report of endotipsitis.American journal of gastroenterology.2016; 111:s897 issn: 15720241.

Event Description

This information was received through abstract "septic thrombus of a transjugular intrahepatic portosystemic shunt (tips) resulting in psoas muscle abscess: a case report of endotipsitis" published in the american journal of gastroenterology, 2016.The abstract presents a case of an infected tips thrombosis that extended through the inferior vena cava (ivc) into the right atrium and resulted in right psoas muscle abscess.The abstract states "an (b)(6) male with a history of cryptogenic cirrhosis requiring tips for diuretic resistant ascites who had suffered a complicated course involving multiple in-stent stenosis necessitating repeat tips and revision presented to an outside facility ed with increasing abdominal girth and back discomfort two weeks after undergoing a second revision with successful placement of a viatorr stent.A contrast-enhanced computed tomography (ct) scan of the abdomen appeared to display contrast within the second tips and no other abnormalities.Although at this time no doppler study was performed and the patient was discharged to home.Three days later the patient returned with worsening back pain.At that time, contrast-enhanced ct revealed an occluding thrombus extending from the origin of the main portal vein to the right atrium, along with scattered thrombi in the infrarenal ivc.A new fluid collection was also seen in the left psoas.Drainage of the psoas abscess was performed.Two blood cultures and abscess fluid culture grew staphylococcus hominis.The patient was transferred to a facility equipped for complex endovascular procedures and underwent an ir-guided thrombolysis of the ivc thrombus with tips revision.The patient subsequently improved and was discharged home with subcutaneous enoxaparin for anticoagulation and four weeks of iv ceftriaxone for bacteremia.".

• Brand Name: GORE VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6498793
• MDR Text Key: 72986934
• Report Number: 3007284313-2017-00092
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 81 YR