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

Model Number	PTB8108275
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis of the production records is in progress.A total of one (1) case image was received via email for evaluation.Based on the imaging provided, a gore® viatorr® device and guidewire are visible.It appears that a portion of the graft-lined region of the viatorr® device remains constrained, while the proximal and distal graft-lined regions are deployed.A full imaging evaluation could not be performed as a result of images not meeting dicom® standard.Based on the available information, this imaging evaluation can neither confirm the reported partial deployment of the viatorr® device nor determine a potential cause.Additionally, this imaging evaluation could not determine the events that occurred during the procedure based on the images received.
Event or Problem Description
It was reported the physician selected a gore® viatorr® tips endoprosthesis with controlled expansion for a transjugular intrahepatic portosystemic shunt procedure.Following device placement, the covered portion of the stent did not fully deploy.Strong resistance was met with the deployment line and as the line was pulled harder, the device was pulled from the desired position.The stent was snared from the patient.Two gore® viatorr® tips endoprostheses with controlled expansion were then implanted with no adverse effects.To the patient.The account reported that the viatorr® device kinked making a sharp turn and that the kink may have led to the deployment line being stuck or pinched when deployment was attempted.
Additional Manufacturer Narrative
One fluoroscopic case image was provided for evaluation.Based on the imaging provided, a gore® viatorr® device and guidewire are visible.It appears that a portion of the graft-lined region of the viatorr® device remains constrained, while the proximal and distal graft-lined regions are deployed.A full imaging evaluation could not be performed as a result of images not meeting dicom® standard.Based on the available information, this imaging evaluation can neither confirm the reported partial deployment of the viatorr® device nor determine a potential cause.Additionally, this imaging evaluation could not determine the events that occurred during the procedure based on the images received.
Additional Manufacturer Narrative
The device was not returned for analysis; however, a engineering evaluation was performed.It was reported that a kink in the device may have led to the deployment line being stuck or pinched.As the device was not returned, it could not be confirmed if the device had a kink, nor that the covered portion of the stent did not fully deploy.Not enough information was provided to determine the cause of the event.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12188996
• Report Number: 3007284313-2021-01509
• Device Sequence Number: 13800586
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: PTB8108275
• Device Catalogue Number: PTB8108275
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 06/24/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/13/2021; 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 87