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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Ischemia (1942); Respiratory Failure (2484)

Event Date 06/01/2015

Event Type  Death  

Manufacturer Narrative

Lopera je, speeg kv, young c, et al.Segmental liver ischemia / infarction after elective transjugular intrahepatic portosystemic shunt creation: clinical outcomes in 10 patients.Journal of vascular & interventional radiology 2015;26(6):835-841.

Event Description

This information was received through literature article " segmental liver ischemia / infarction after elective transjugular intrahepatic portosystemic shunt creation: clinical outcomes in 10 patients" published in journal of vascular & interventional radiology, 2015.This article is a retrospective review of 10 patients who underwent elective tips creation between (b)(6) 2006 and (b)(6) 2014.Nine of the 10 patients received a gore viatorr tips endoprosthesis, and one patient received a wallstent device.The article does not clarify which patients received viatorr devices.The article reports that following the elective tips procedure, this patient presented with liver ischemia/infarct, followed by acute liver and respiratory failure.The patient died 23 days after the primary procedure.

• 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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5617249
• MDR Text Key: 43947787
• Report Number: 2017233-2016-00415
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• 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 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): Death
• Patient Age: 54 YR