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

Catalog Number PTB086275W

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Thrombosis (2100)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device lot numbers were not available.The images and device were no available , the imaging evaluation and engineering evaluation could not be performed.Two item numbers were used in literature, it was unknown which device was involved in the event.In this event, the second item number was ptb088275w.

Event Description

The following publication was reviewed: "feasibility and clinical value of tips combined with subsequent antitumor treatment in hcc patients with refractory ascites" received through "elsevier".The authors: huzheng yan, guobao wang, wenliang zhu, et al.The article aimed to utilize a transjugular intrahepatic portosystemic shunt (tips) combined with subsequent antitumor treatment is explored in this study for its feasibility and clinical value.From may 16, 2016 to january 17, 2020, 68 hcc patients with portal hypertension-related ra from 3 centers of interventional radiology were enrolled in this study.All of the patients received tips combined with sequential antitumor therapy.After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced in all patients(viatorr; w.L.Gore & associates, inc., flagstaff, az, usa).The specifications of the covered stents were 8 mm-60 mm, 8 mm-80 mm.The results state that a total of 10 (14.7%) patients were diagnosed with shunt dysfunction used with cdus during follow-up.The primary patency rates at 30 and 90 days were 95.6% (65/68) and 89.7% (61/68), respectively.Thrombosis occurred in 3 patients within 30 days after the tips insertion, and tumor invasion led to shunt dysfunction as diagnosed by ct in 7 patients.Among these patients with shunt dysfunctions, tips revision using balloon dilation or additional stent placement were performed in 2 and 5 patients, respectively.Only 1 (1.5%) patient developed acute liver failure and died 11 days after tips.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11044316
• MDR Text Key: 222652851
• Report Number: 3007284313-2020-01204
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PTB086275W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• 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: 58 YR