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

Device Problem Complete Blockage (1094)

Patient Problem Thrombus (2101)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Literature citation: cui j, smolinski se, liu f, xu d, dulaimy k, irani z.Incrementally expandable transjugular intrahepatic portosystemic shunts: single-center experience.American journal of roentgenology 2018 210:2, 438-446.Doi.Org/10.2214/ajr.17.18222.This article was published in february 2018, therefore, (b)(6) 2018 was selected as the event date.Device information was not provided, therefore, an investigation was unable to be performed and a cause of the reported event was unable to be determined.In the gore® viatorr® tips endoprosthesis instructions for use (ifu), thrombus is listed as a possible adverse event and the ifu states that thrombus formation in the tips usually occurs early and may be caused by hypercoaguable syndromes, inadequate coverage of the tips tract, leakage of bile into the tract, or technical complications during the procedure.Additionally, the ifu instructs the user to select an appropriately sized gore® viatorr® tips endoprosthesis for implantation based on the shunt¿s length and diameter.The graft-lined length of this device should be selected to completely line the tips to the ostium of the hepatic vein at the inferior vena cava.

Event Description

This information was received through literature article "incrementally expandable transjugular intrahepatic portosystemic shunts: single-center experience" published in american journal of roentgenology, february 2018.The article reports one patient with a gore® viatorr® tips endoprosthesis implant underwent stent successful tips recanalization with shunt extension to the inferior vena cava two days following the primary procedure due to thrombus.

• 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: 8816957
• MDR Text Key: 151890548
• Report Number: 3007284313-2019-00216
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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): Required Intervention
• Patient Age: 57 YR