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

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Dyspnea (1816); Dizziness (2194)

Event Date 03/14/2014

Event Type  Injury  

Manufacturer Narrative

To date, no additional information regarding this event, including specific patient and device information, has been provided to gore.De winter s, verelst s, wauters j, et al.Pharmacokinetic changes after placement of a transjugular intrahepatic portosystemic shunt.European journal of clinical pharmacology 2014;70(3):377-378.

Event Description

This information was received through letter to the editor "pharmacokinetic changes after placement of a transjugular intrahepatic portosystemic shunt", published in the european journal of clinical pharmacology, 2013.The letter reports a patient with end-stage liver cirrhosis underwent tips placement with a gore viatorr tips endoprosthesis for variceal bleeding and ascites.After tips placement, the patient developed dyspnea and drowsiness due to severe sinus bradycardia.The patient was transferred to the emergency department where beta blocker and calcium channel antagonist intoxication along with resulting cardiogenic shock was assumed.Glucagon in combination with noradrenaline and dobutamine were administered the first day and the patient was discharged on day 16.The authors suggest an increase in bioavailability, and therefore the potential for toxicity, of drugs with low and intermediate bioavailability by shunting the liver due to tips placement.

Manufacturer Narrative

The article was published in the (b)(4) journal of clinical pharmacology in 2014.The initial 30-day medwatch description of event had an incorrect year of publication (2013).

• 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: 5255997
• MDR Text Key: 32347925
• Report Number: 3007284313-2015-00134
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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): Hospitalization; Life Threatening; Other
• Patient Age: 76 YR