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

Catalog Number PTB087275W

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that the lot met all pre-release specifications.The engineering evaluation stated that the device was returned with the endoprosthesis partially constrained between the introducer sheath and the catheter with the access sleeve pulled back from the tip of the catheter.During the engineering evaluation and after removal of the sheath, the device was successfully deployed.Further inspections revealed no other device abnormalities.Based on the returned state, it is possible that the deployment line became stuck because the endoprosthesis remained partially constrained within the introducer sheath.However, once the introducer sheath was pulled completely off the endoprosthesis during the engineering evaluation, the device was deployed successfully.

Event Description

It was reported to gore that the physician was implanting a gore® viatorr® tips endoprosthesis for a treatment of the haematemesis of upper digestive tract and spitting blood for 5 days.The device was advanced through a cook rups100 sheath over an ev.3 guide wire.It was stated that there was some resistance during inserting through the sheath, but extra force still can continue insertion.After the device was advanced to the portal vein, the physician withdrew the sheath to deploy the lined region firstly.To ensure the golden circumferential radiopaque marker being at the junction of portal vein and liver parenchyma, the physician wanted to withdraw the catheter and adjust but a resistance was felt.The physician tried moving the catheter back and forth to overcome the resistance, however the catheter was reportedly stuck in the sheath so could not move.During attempt of catheter adjustment, a part of line region was observed protruding out of the sheath and expanded under angiography, even the physician never pulled the deployment knob.The physician decided to retract the device, there was also difficulty but finally able to retract the device out of the patient together with the sheath after several attempts.The physician used a new viatorr® device of the same size to continue the procedure.The procedure was completed successfully and the patient recovered well.

Manufacturer Narrative

Engineering evaluation result updated.The engineering evaluation stated that the device was returned with the endoprosthesis partially constrained between the introducer sheath and the catheter with the access sleeve pulled back from the tip of the catheter.During the engineering evaluation and after removal of the sheath, the device was successfully deployed.Further inspections revealed no other device abnormalities.Based on the returned state, it is possible that the deployment line became stuck because the endoprosthesis remained partially constrained within the introducer sheath.However, once the introducer sheath was pulled completely off the endoprosthesis during the engineering evaluation, the device was deployed successfully.Based on the additional information, a summary of the addendum to the initial engineering evaluation was further provided as following.It is unclear why the physician felt resistance while inserting the device through the sheath and while withdrawing the catheter after the device was advanced to the portal vein, as described in the additional communication received from the physician.It is unclear as to why the zipper backset was returned at 3.9 cm.If the zipper backset location shifted proximally, the portion of the lined region of the device that is no longer constrained would self-expand.Not enough information was provided to discern why resistance was felt during insertion and withdrawal of the catheter.Additionally, not enough information was provided to identify the cause of the zipper backset shifting or the cause of the expansion of a portion of the lined region prior to pulling the deployment line.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7528793
• MDR Text Key: 108905382
• Report Number: 3007284313-2018-00157
• 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: 05/30/2018

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: 07/13/2020
• Device Catalogue Number: PTB087275W
• Device Lot Number: 16501850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR