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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

The gore® viatorr® tips endoprosthesis instructions for use list shunt stenosis or occlusion as adverse events that may occur and/or require intervention.

Event Description

This information was received through literature article "causes and rates of 30-day readmissions after transjugular intrahepatic portosystemic shunts" published in the american journal of roentgenology, july 2020.The purpose of this retrospective study was to investigate the causes and rates of 30-day readmission after transjugular intrahepatic portosystemic shunt (tips) at a single liver transplant center between 2003 and 2013.149 patients were included for readmission analysis.Five patients presented with a recurrence of symptoms (rebleeding or ascites) and were found to have tips stenosis or occlusion.Tips revision with extension of the tips stent to the hepatic vein¿inferior vena cava junction was required in all patients.In this study, these readmissions were found to have early tips stenosis because the cranial extent of the tips did not reach that junction.Subsequent extension of the tips with stent placement up to the hepatic vein¿inferior vena cava junction successfully resolved the presenting clinical symptoms for each readmitted patient.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10897931
• MDR Text Key: 218236436
• Report Number: 3007284313-2020-01169
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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
• Date Manufacturer Received: 10/28/2020
• 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): Required Intervention
• Patient Age: 56 YR