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

Catalog Number PTB086275W

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore that the physician was implanting a gore® viatorr® tips endoprosthesis for a treatment of the portal vein hypertension due to the cirrhosis.The device was advanced through a 10fr cook rups100 sheath via a super stiff guide wire.After the device was well positioned, the physician pulled back the sheath to deploy the chainlink portion of device, then started initiating deployment of lined region.However when the lined region was deployed half, a resistance was reportedly felt and the deployment was not able to continue.The physician exchanged the 10fr sheath with an 11fr sheath then retracted the partially deployed viatorr® device out of the patient through the 11fr sheath, there was no reported issue or injury to the patient during the device retraction.The physician used another viatorr® device of same size to continue the procedure.The procedure was completed successfully.

Manufacturer Narrative

Code 10 - the engineering evaluation result stated that during the engineering evaluation, the device was successfully deployed.Further inspection revealed no other device abnormalities.The engineering evaluation was unable to confirm the physician¿s observation of ¿deployment was not able to continue¿, as during the engineering evaluation the constrained portion of the device successfully deployed without abnormalities.Not enough information was provided to discern why the device experienced a resistance and the deployment was unable to continue.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7528976
• MDR Text Key: 109236691
• Report Number: 3007284313-2018-00158
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Catalogue Number: PTB086275W
• Device Lot Number: 17268183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 61