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

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/05/2013

Event Type  Injury  

Manufacturer Narrative

Parvinian a, bui jt, knuttinen mg, minocha j, gaba rc.Transjugular intrahepatic portosystemic shunt for the treatment of medically refractory ascites.Diagnostic & interventional radiology 2014;20(1):58-64.

Event Description

This information was received through literature article "transjugular intrahepatic portosystemic shunt for the treatment of medically refractory ascites" published in diagnostic & interventional radiology, 2014.This retrospective study included 80 patients in the study cohort.Ten patients received 10 or 12mm wallstent bare metal stents, and 70 of the 80 patients received 10mm covered stents (gore viatorr tips endoprostheses).The article reports a 30-day procedure-related event of liver insufficiency requiring shunt reduction in one patient.It was not specified which device (bare metal or covered stent) was used in this patient.

Manufacturer Narrative

(b)(4).

• 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 86001
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5258023
• MDR Text Key: 32407507
• Report Number: 2017233-2015-00844
• 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,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• 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): Other
• Patient Age: 56 YR