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

Catalog Number PTB8108275

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted so no engineering investigation could be performed.(b)(4).

Event Description

It was reported that the physician was implanting a gore® viatorr® tips endoprosthesis with controlled expansion for a transjugular intrahepatic portosystemic shunt (tips) procedure.The patient presented with non occlusive portal vein thrombosis prior to tips implantation.The device was deployed to 8mm.According to the physician, the device appeared to completely cover the hepatic vein to the inferior vena cava on ct.The device was deployed and implanted without incident.The physician brought the patient in for a one-week follow up.The physician did not see any flow through the device under ultrasound and thought it may just be due to the wet-out of the ptfe device.The patient was brought back in due to worsened ascites and to re-do the ultrasound one week later (two weeks post implant) and the physician could still not see any flow through the device under ultrasound.Thrombosis of the device was suspected.The physician performed a venogram to determine the patency of the device.The venogram showed that the stent and portal vein had thrombosed and also showed thrombus in the smv.The physician is planning for the patient to get lysed overnight.After the patient was lysed, the patient came back for thrombectomy (angio jet, boston scientific).The physician dilated the viatorr cx stent and relined half of the viatorr cx with a covered stent and extended into the ivc.The physician lined the portal vein with a bare metal stent.The physician reports that the patient did very well.The patient was put on anticoagulants for 6 months.The physician stated that he can't say for sure that the thrombus was due to the device because there was preexisting portal vein thrombosis.

• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7506371
• MDR Text Key: 107985860
• Report Number: 3007284313-2018-00149
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2021
• Device Catalogue Number: PTB8108275
• Device Lot Number: 17738999
• 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: 02/03/2018
• 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): Other
• Patient Age: 62 YR