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

Model Number PTB8106275

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

During the deployment of a covered stent, the uncovered part of the stent deployed into the patient properly but then to finish deploying the covered part, the md needed to unscrew a plastic wheel which releases the covered part of the stent.In this case, the plastic wheel locked up and could not be opened, leaving the stent stuck in the patient half-deployed.The md was able to break the plastic wheel part off and grasp the string and deploy the stent properly.There was no harm to the patient.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st; flagstaff AZ 86004
• MDR Report Key: 12744164
• MDR Text Key: 279828717
• Report Number: 12744164
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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
• Device Lot Number: 23175097
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other