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

Device Problems Retraction Problem (1536); Difficult or Delayed Activation (2577); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  Injury  

Event Description

During tips procedure, viatorr controlled dilation 8-10 mm x 80 mm device was positioned with uncovered component in the right portal vein and the covered portion in the parenchymal tract.The deployment thread was pulled and instead of releasing the device, the thread twisted the device and caused the device to retract and a loop to form in the device despite an amplatz wire being used to stabilize the device.Once pulling on thread stopped the device straightened out over the wire but was significantly retracted into the parenchymal tract and the downstream portion was well into the ivc at the level of the cavoatrial junction.At this point, the thread would not retract further and any retraction cause device to pull further into parenchymal tract.The device was stabilized with the 10 fr sheath and fortunately with significant force, the thread was slowly able to be retracted and the device released.A new controlled dilation viatorr 8-10mm x 50 mm device had to be deployed into the parenchymal tract to allow adequate covered portion to be in the parenchymal tract.Both viatorr devices were post dilated with 8 mm balloon.The patient required additional imaging including echo and ct as well as holter monitor to assess for arrhythmias.Fda safety report id # (b)(4).

• Brand Name: VIATORR
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): GORE W. L. GORE & ASSOCIATES, INC
• MDR Report Key: 13290217
• MDR Text Key: 284134203
• Report Number: MW5106777
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male