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

Model Number	PTB8106275
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient weight was available.The imaging summary stated the following: based on the imaging provided, a gore® viatorr® device, introducer sheath, and guidewire are visible.The distal portion of the graft-lined region of the viatorr® device deployed, while the proximal graft-lined region of the device remains undeployed.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
The physician was performing a tips procedure using a 10 fr cook introducer sheath and a gore® viatorr® tips endoprosthesis with controlled expansion.The physician was able to successfully deploy the unlined, chain-link portion of the device in the portal vein and began to deploy the graft-lined region of the device.The physician reported that approximately half-way through pulling the deployment line that it stopped and felt ¿locked¿.The physician reported that he continued to apply such force to attempt deployment that the amplatz guidewire kinked.The physician then exchanged for a new amplatz guidewire, and continued to attempt full deployment, which remained unsuccessful.The physician reported that he then attempted to re-sheath the partially deployed device but was unsuccessful.The physician cut the back end of the delivery catheter off to remove the 10 fr cook introducer sheath and upsized to a 12 fr cook introducer sheath, to remove the device through the larger sheath.It was reported that the physician still was not able to completely re-sheath the device for removal.The physician then inserted a snare catheter to capture the device and was able to successfully remove the device from the patient without the need for a cutdown or surgical intervention.A new viatorr® device was then implanted without issue.The physician reported that the patient was doing well.

• 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: 12227650
• Report Number: 3007284313-2021-01523
• Device Sequence Number: 4869096
• Product Code: MIR
• UDI-Device Identifier: 00733132635023
• UDI-Public: 00733132635023
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 07/26/2021

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: 02/20/2024
• Device Model Number: PTB8106275
• Device Catalogue Number: PTB8106275
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR