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

Catalog Number PTB106275

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results code 1: 213 - a review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician selected a gore viatorr tips endoprosthesis for a transjugular intrahepatic portosystemic shunt (tips) procedure.Half way through deployment, the deployment line became stuck and stent deployment could not be completed.The device could not be pulled back into the delivery sheath and was removed from the patient partially deployed.A 14fr vascular catheter was then used to deliver a second 10mm x 6cm gore viatorr tips endoprosthesis and the case was concluded with no adverse events.The patient was doing well following the procedure.

Manufacturer Narrative

The device was returned to gore for analysis.The device was returned partially deployed and partially constrained by the zipper.The deployment knob was not attached to the catheter at the hub, which is consistent with a device where deployment has been initiated.The distal portion of the catheter was not connected to the catheter shaft and not returned with the device.The device was bent where the catheter shaft connects to the hub.The deployment line appeared to cut through the catheter approximately 18mm from the distal port.From where the deployment line cut through the catheter, there was an etched line along the catheter approximately 8.5cm in length with a region that cut through the catheter.The zipper backset was where expected for a device where zipper deployment has been initiated.There was tape damage on the unconstrained endoprosthesis.This is consistent with damage that would occur when attempting to retract an unconstrained device through a valve or sheath, as reported in the event description.There were 3 strands of broken zipper fibers on the deployment line.During the engineering evaluation, deployment was attempted but no further deployment was achieved.Without a more detailed description of all the activities involved in the use of this device, it is impossible to determine the failure mode with complete assurance.This engineering evaluation was unable to determine why the deployment line became stuck during deployment.The distal portion of the catheter detached from the catheter at the distal tip to catheter shaft bond as a result of tensile forces applied to the catheter.The engineering evaluation was unable to discern the source of the force.It is likely that the deployment line cut through approximately 18mm of the catheter proximal to the distal port due to excess force on the deployment line to get it unstuck during deployment.The engineering evaluation was unable to determine how or why there was an 8.5cm long etched line on the catheter, but it appears the etched line could be made with a blade or scalpel.The engineering evaluation was also unable to determine how the zipper fibers broke on the deployment line.All devices are inspected before they are released from gore: the catheter shaft is inspected for kinks, cuts and nicks.The zipper/deployment line is inspected for nicks, cuts, and frays.The endoprosthesis is inspected for tape damage and delamination.The endoprosthesis could not have been loaded onto the catheter without the distal portion of the catheter.The working length of the catheter is confirmed.Per the manufacturing evaluation, the device met pre-release specifications.

• Brand Name: GORE VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6572301
• MDR Text Key: 75526268
• Report Number: 3007284313-2017-00124
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: PTB106275
• Device Lot Number: 14821029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 93