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

Model Number PTB8106275

Device Problems Difficult to Fold, Unfold or Collapse (1254); Activation Problem (4042)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

Documentation from provider: stenting was performed using a 6 mm gore viatorr endoprosthesis with controlled expansion.The stent was deployed within the main portal and the uncovered portion pulled back to the parenchymal boundary.The sheath was withdrawn to the right atrium.An attempt was made to deploy the stent, however, the stitching would not unravel.Communication with the company representative advised to not pull harder on the deployment mechanism and remove the system after resheathing the stent.A 10 french sheath was then pushed over the covered portion of the stent with little difficulty.However, the deployed uncovered stent portion would not collapse.This system was then removed as one unit leaving wire access.Once the system was brought through the jugular, it was noted that the picc had also been pulled through.Manual pressure was used for hemostasis.The patient's picc was then removed from the arm access.The 10 french sheath was replaced.A new 6 mm gore viatorr endoprosthesis with controlled expansion was brought into the main portal vein and deployed in a similar fashion.Device was picked up by carrie brown with wl gore.Fda safety report id # (b)(4).

• Brand Name: TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): WL GORE & ASSOCIATES, INC.
• MDR Report Key: 14257489
• MDR Text Key: 290561189
• Report Number: MW5109452
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PTB8106275
• Device Catalogue Number: PTB8106275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PICC LINE
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male