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

Catalog Number	PTB8108275
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gore® viatorr® tips endoprosthesis delivery catheter and deployment line were returned for analysis (stent remains implanted).The catheter was inspected and there was no zipper attached at the proximal bump.No other anomalies were observed on the catheter.The deployment line was inspected and found to be broken.The break appeared to be indicative of a tensile break.The returned deployment line only measured 86 cm, indicating that a part of the deployment line remained with the device or was not returned.The engineering evaluation could not determine why the deployment line became stuck and eventually broke, or why there were two sections of the stent that were not fully open.(b)(4).
Event or Problem Description
It was reported the physician selected a gore® viatorr® tips endoprosthesis for a transjugular intrahepatic portosystemic shunt procedure.The device was placed and the bare metal portion was deployed without issue.After deploying approximately one third of covered portion of the stent, the deployment line became stuck.Several maneuvers were attempted to fully deploy the stent; however, the deployment line eventually broke.The delivery system was removed and a balloon was advanced into the stent to attempt and release the remaining constrained portion.Following this process, there were two sections of stent that were not fully open.The procedure was concluded and there were no reported adverse effects to the patient.
Additional Manufacturer Narrative
Additional information provided from the engineering analysis is as follows: a sample 8-10mm x 8/2cm device was deployed and the deployment line removed and measured to compare to the length of deployment line returned.The deployment line of the sample device measured 119cm.The returned deployment line measured 86cm, suggesting that a part of the deployment line may remain with the device or was not returned.Engineering was not able to determine if and how the deployment line was stuck, as the endoprosthesis remains in the patient.Imaging evaluation results: case imaging was received by gore evaluation.From the imaging provided, it is unclear if the deployment of the graft lined region was initiated prior to the sheath being fully retracted.The gore® viatorr® tips endoprosthesis with controlled expansion instructions for use step 14 states: ¿once the optimal device position is verified and the hemostatic introducer sheath is fully withdrawn, deploy the remaining graft-lined region of the gore® viatorr® tips endoprosthesis.¿ this evaluation was able to confirm that several maneuvers were attempted to fully deployed the stent, which appeared to be manipulation of the sheath and moving it back and forth over the device, and tugging on the deployment line.Any additional maneuvers to attempt device deployment could not be identified or confirmed with the available information.This evaluation confirmed that dilation balloons were inserted into the stent graft to attempt to dilate the undeployed sections.However, the type and specifications of the balloons were not able to be confirmed with the currently available information.The final angiogram on the set of images that was returned to gore showed the viatorr® with two nondeployed sections and contrast pooling in the deployed regions, indicating lack of blood flow through the device.The cause for the deployment line becoming stuck after one-third of the covered portion of the stent was deployed could not be determined with the available information.However, it may be possible that a sheath covering the graft-lined region during deployment affected deployment.Similarly, this evaluation is unable to confirm where and how the deployment line broke.This imaging evaluation was able to confirm that there were two sections of stent that were not fully open.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8654241
• Report Number: 3007284313-2019-00160
• Device Sequence Number: 19474570
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 03/08/2022
• Device Catalogue Number: PTB8108275
• Device Lot Number: 20331020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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: 51 YR