W.L. GORE & ASSOCIATES GORE VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
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Device Problem
Insufficient Information (3190)
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Patient Problems
Bradycardia (1751); Dyspnea (1816); Dizziness (2194)
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Event Date 03/14/2014 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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).
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