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

Device Problems Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis (2100)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

The gore® viatorr® tips endoprosthesis instructions for use precaution section notes the graft-lined portion of the gore® viatorr® tips endoprosthesis should completely cover the intrahepatic tract, preferably to the ostium of the hepatic vein at the inferior vena cava.Additionally, thrombosis is listed as a possible adverse event in the gore® viatorr® tips endoprosthesis instructions for use.Regnaulta d, d¿alterochea l, nicolasa c, dujardinb f, ayoubc j, perarnau jm.Ten-year experience of transjugular intrahepatic portosystemic shunt for noncirrhotic portal hypertension.European journal of gastroenterology & hepatology 2018; 30:557¿562.

Event Description

This information was received through literature article "ten-year experience of transjugular intrahepatic portosystemic shunt for noncirrhotic portal hypertension" published in the european journal of gastroenterology and hepatology, may 2018.The study is a monocentric retrospective study concerning patients treated by tips between 2004 and 2015 for complications of noncirrhotic portal hypertension.The article reports an early complication (< 30 days) with a gore® viatorr® tips endoprosthesis.An asymptomatic early thrombosis was detected via ultrasound on day five following implant.It was further reported that too short a stent was initially placed requiring a new and longer 1 cm stent.

• 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: 7779221
• MDR Text Key: 116996732
• Report Number: 3007284313-2018-00225
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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 the Report Sent to FDA?: No
• 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: 56 YR