Medical device manufacturer, W. L. Gore & Associates Inc, has issued a medical device safety alert concerning its Conformable TAG Thoracic Endoprosthesis (CTAG) [Manufactured between 4 May 2016 and 3 May 2017].
Since December 2016, the manufacturer has received reports globally of incomplete and/or partial deployments of the CTAG Device. In each event the physician observed that half of the CTAG Device deployed and half remained constrained to the delivery catheter. Engineering evaluations for two returned devices indicated that one partial deployment was the result of an incorrect deployment line stitch pattern and another was the result of a damaged deployment line (of an unknown origin). The other two devices have not been returned to the manufacturer. Potential failure modes from all events have not been determined and the investigation is on-going.
According to the manufacturer, there were 4 similar reports of incomplete and/or partial deployments in 12800 units of TAG Thoracic Endoprosthesis, with frequency of 0.03%. Each of these events was considered an off-label procedure. None of these reports were submitted from Hong Kong. Besides, the incomplete deployments are known adverse events and identified in the Instruction For Use (IFU). The device is not considered violative or defective, no failure meeting product specifications. The manufacturer has also determined that there is no need for market withdrawal or recall of the product. There are no actions required for patients already implanted with a Conformable TAG Device.
The manufacturer issues Physician Safety Information Letter and updated IFU warnings and precautions.
According to the local supplier, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 September 2017