W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number TGM343420 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Aortic Dissection (2491)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the manufacturing records for the device verified that the lot met all pre-release specifications.
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Event Description
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On (b)(6) 2020, the patient was implanted with conformable gore® tag® thoracic endoprosthesis with active control system (ctag-ac) to treat a thoracic dissection in zone 0 deployment.It was reported that when the primary deployment line was pulled, the device deployed at 50% and the line came out of the back of the delivery handle.The distal end of the device was not deployed, so the secondary line was deployed, still only partial deployment of device but the device was released from the delivery catheter.The physician used a pigtail catheter and manipulation with a guide wire and was able to deploy the device to full deployment.The patient tolerated the procedure.
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Manufacturer Narrative
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Addition the device was returned to gore histology for an engineering evaluation.Per the evaluation the primary deployment line (pdl) that remained connected to the primary deployment knob measured approximately 92.6cm.This is significantly shorter than the approximate 188.5cm pdl attached to the deployment knob of a fully deployed primary sleeve on a separate 34x34x20 device.Based on the evaluation, the reason for the reported incomplete primary sleeve deployment appears to be that the primary deployment line broke.Based on the information available and the evaluation of the returned device, no root cause could be confirmed.
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