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

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

Event Date 06/17/2004

Event Type  Injury  

Manufacturer Narrative

As there is no further information about the status of the device until now and the serial no.Is unknown, no further investigations can be performed at the moment.Date of event was determined as date when literature article was accepted, here (b)(6) 2004.As patient age the mean age of 52 years was determined and as gender male as mentioned in the article.

Event Description

Within the article ¿results of a retrospective multicenter trial of the viator expanded polytetrafluoroethylene (eptfe) ¿ covered stent-graft for transjugular intrahepatic portosystemic shunt creation (tips)¿ from jean-pierre m.Charon published in the journal of vascular interventional radiology 2004; 15:1219-1230 the following was indicated: purpose was to report the results of a multicenter experience with the viator eptfe covered stent-graft for tips creation in which patency and clinical outcome were evaluated.One hundred consecutive patients with portal hypertension, with a mean age of 52 years (range, 22¿86 years), underwent implantation of the viator tips stent-graft at one of three hospital centers.The indications for tips creation were variceal bleeding (n=81) and refractory ascites (n=19).One case resulted in acute repeat intervention (within 30 days) which was required for portal vein thrombosis.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10777924
• MDR Text Key: 214403486
• Report Number: 3007284313-2020-01143
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 52 YR