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

Catalog Number PT108275

Device Problems Complete Blockage (1094); Off-Label Use (1494)

Patient Problem Thrombosis (2100)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

The gore® viatorr® tips endoprosthesis instructions for use list thrombosis and occlusion as possible adverse events.Treatment of portal vein thrombosis is off-label use.Additionally, cavernous portal vein occlusion or splenic vein thrombosis is listed as a contraindication in the ce marked approved ifu.Literature article citation: daniel kuetting, karsten wolter, julian luetkens et al.Polish journal of radiology 2018;83:e536-e544 doi: 10.5114/pjr.2018.81380.

Event Description

This information was received through literature article "angio-jet-assisted transvenous-transhepatic mechanical thrombectomy in the portal vein" published in the polish journal of radiology, december 28, 2018.The article reports four patients with acute and acute-on-chronic total portal vein and mesenteric vein thrombosis underwent transvenous thrombolysis.Additionally, transjugular intrahepatic portosystemic shunts (tips), using viatorr stent grafts were implanted in all patients.Following tips implantation complete portal vein (pv) recanalisation could be achieved in all acute cases.In the acute-on-chronic case, ultrasound performed 10 days after implantation of tips revealed subtotal thrombotic tips occlusion.The patient was referred to interventional radiology again to attempt tips and pv recanalisation.By means of aspiration thrombectomy and thrombolytic therapy, pv and tips were successfully recanalised; however, the tips re-occluded again 10 days later.Another attempt to re-establish pv patency was not undertaken.Duplex sonography performed two months and 12 months after intervention showed a complete occlusion of the tips tract and the splanchnic venous system with cavernous transformation of the portal vein.Gastroscopy revealed oesophageal varices i°, psychometric testing re-vealed no signs of hepatic encephalopathy, and laboratory follow-up showed normal values of liver enzymes.

Manufacturer Narrative

On the initial report, catalog # was populated with "pt108275".However, the article noted that three catalog numbers were used: pt106275, pt107275, and pt108275.It is unknown which size was used for the patient in this report.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9214759
• MDR Text Key: 175257558
• Report Number: 3007284313-2019-00318
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PT108275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR