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

Catalog Number PTB108275

Device Problems Break (1069); Difficult or Delayed Activation (2577); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.Udi: (b)(4).

Event Description

It was reported the physician selected a gore® viatorr® tips endoprosthesis for a transjugular intrahepatic portosystemic shunt procedure.The device was advanced and placed in the desired location.Two thirds of the device was deployed when the deployment line became stuck and full deployment could not be completed.The physician made multiple attempts to complete deployment using endovascular techniques, but was unsuccessful.A direct portal stick was performed and a snare was used to capture the end of the guidewire in attempt to better maneuver the stent/deployment line.Deployment was again attempted; however, the deployment line broke along with approximately 10-12cm of the delivery catheter.A 16fr sheath was introduced and the delivery catheter fragment was snared from the patient.A 5mm balloon was then advanced and deployed inside the stent in an attempt to complete deployment, but the balloon broke and was removed.A non-compliant balloon was then advanced and deployed; the stent opened completely and remains implanted.There were no reported adverse effects for the patient.

Manufacturer Narrative

The stent remains implanted; however, the delivery system was returned for analysis.The deployment line was returned in 3 pieces.Some of the ends of the pieces were frayed, which is indicative of a tensile break.The distal shaft of the catheter was detached from the shaft of the catheter.There was an etched line in the catheter from the distal port to approximately 6cm proximal to the distal port.The deployment line was no longer connected to the catheter, which is consistent with the physician¿s observation that the deployment line broke in the second attempt to deploy the endoprosthesis.It is unclear why the deployment line was returned in three pieces.The distal shaft of the catheter was not attached to the catheter and was 11.5cm long, which is consistent with the physician¿s observation that approximately 10-12cm of the delivery catheter broke.The distal shaft of the catheter detached from the catheter shaft as a result of tensile forces experienced during the procedure.The engineering evaluation was unable to determine how or why there was a 6cm long etched line on the catheter near the distal port, but it appears the etched line could be made with a blade or scalpel.The cause for the deployment line becoming stuck could not be determined with the currently available information.The deployment line and delivery catheter broke due to the above-normal tensile force used to attempt complete deployment.

• 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: 7199152
• MDR Text Key: 97960081
• Report Number: 3007284313-2018-00020
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: PTB108275
• Device Lot Number: 17385379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2017
• 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