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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS Back to Search Results
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).
 
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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 Key5255997
MDR Text Key32347925
Report Number3007284313-2015-00134
Device Sequence Number1
Product Code MIR
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P040027
Number of Events Reported1
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
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/21/2015
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 Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other;
Patient Age76 YR
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