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

Catalog Number PT107275

Device Problem Pressure Problem (3012)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 09/01/2013

Event Type  Injury  

Manufacturer Narrative

A device lot number was not provided; therefore, a review of the manufacturing records cannot be performed.The device remains implanted.Literature citation: (b)(6) cardiac arrest after transjugular intrahepatic porto-systemic shunt creation in a (b)(6) year-old patient with end stage liver disease secondary to cystic fibrosis.Journal of gastrointestinal and liver disease 2013;3:362.

Event Description

This information was received through literature article "cardiac arrest after transjugular intrahepatic porto-systemic shunt creation in a (b)(6)-old patient with end stage liver disease secondary to cystic fibrosis" published in journal of gastrointestinal and liver disease, (b)(6) 2013.The article reports that following deployment of a 10mm gore viatorr tips endoprosthesis during a transjugular intrahepatic portosystemic shunt procedure, hemodynamic measurement showed a severe increase in the right atrial pressure.Directly following completion of the procedure the patient's oxygen saturation decreased progressively with severe bradycardia and cardiac arrest.Adrenaline intravenous infusion, cardiac massage and administration of 20ppm of inhaled nitric oxide were performed for around two minutes until spontaneous cardiac activity was restored.The patient was transferred to the intensive care unit for 24 hours.Eight days following this postprocedural complication, the patient was discharged home.The patient no longer requires paracentesis for ascites given that it has resolved in 6 months of follow up.

Manufacturer Narrative

A device lot number was provided by the corresponding author.A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).Additional information received from the corresponding author: tips creation, although very risky in this kind of patient, was proposed as a bridge to transplantation.Tips creation in cf patients is a very unusual procedure with very few cases reported.I do not think viator stent was in any case responsible of the complication, i think it would have be the same using a wallstent or other covered stent.In our patient the presence of subclinical pulmonary hypertension was likely responsible for this major immediate complication.The hypertrophy of the muscular layer of the pulmonary arteries secondary to chronic hypoxemia, might have reduced the capacity of the pulmonary vessels and right heart to compensate for the acute volume overload secondary to tips creation.

• 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: 5054906
• MDR Text Key: 24996252
• Report Number: 3007284313-2015-00095
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: PT107275
• Device Lot Number: 10173080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2012
• 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; Required Intervention
• Patient Age: 28 YR