Conformable GORE TAG Thoracic Endoprosthesis 의 리콜

Recall

RC-2017-RN-01255-1

Class I

2017-10-09

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01255-1

W.L. gore has received 4 reports of incomplete and/or partial deployment of the conformable gore tag device during endovascular procedures. in each event, half the device deployed and half remained constrained to the delivery catheter. there have been 2 serious adverse health consequences and 1 death related to this issue.New warnings and precautions are being added to the instructions for use (ifu):- if abnormal or inconsistent deployment line resistance is felt during deployment initiation, stop deployment action immediately. if device remains constrained, remove device through the introducer sheath. if resistance is felt during removal through the sheath, stop and withdraw device and introducer sheath together.- if the device is in a partially deployed state and remains attached to the catheter, physicians should strongly consider conversion to immediate open surgical repair to avoid additional procedure time and potential harm from additional endovascular manoeuvres.

Gore is providing users with updated Instructions for Use (IFU) including additional warnings and precautions. There are no actions required for patients already implanted with a Conformable TAG Device. Patients who have been implanted with a device do not require any change to their usual follow-up plan, and should continue to be monitored in accordance with standard practice.