W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGU454515J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Air Embolism (1697); Infarction, Cerebral (1771)
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Event Date 01/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Per the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, neurologic damage.See also mfg report# 2017233-2020-00100.
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Event Description
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On (b)(6) 2020, a patient underwent a treatment of thoracic aortic aneurysm with conformable gore® tag® thoracic endoprostheses.After an ax-ax bypass was performed, tgu454515 was placed under the lcca.Then an embolization of the origin of the lsa using coil and plug was performed.Although the procedure was completed without any problem, the patient did not recover from anesthesia.A stroke was suspected and an mri was conducted.The mri revealed a cerebral infarction.The physician suspected a thromboembolism, and an unknown medication was administered.On (b)(6) 2020, the patient was reported to still be unconscious, but was in the icu and breathing spontaneously.The physician now suspects an air embolism.No additional intervention is planned.
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Manufacturer Narrative
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Method code - code 3331 added for results of manufacturing evaluation.Code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Code 22 ¿ according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, neurologic damage.See also mfg report# 2017233-2020-00100.
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Search Alerts/Recalls
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