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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Catalog Number TGMR404020J |
Device Problem
Unintended Movement (3026)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device remains implanted and is not available for investigation.Further information was requested but was not available.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, endoprosthesis migration and reoperation.
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Event Description
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On (b)(6) 2020, the patient underwent endovascular treatment of a type b aortic dissection using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2021, a distal migration (distance unknown) and ulcer-like projection (ulp) forming were observed.On (b)(6) 2021, a reintervention placing additional gore® tag® conformable thoracic stent grafts with active control system was performed.The patient tolerated the procedure.It is unknown what caused the device migration.Also, the cause of the ulcer-like projection (ulp) forming is unknown.Further information was requested but was not available.
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Event Description
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On (b)(6), 2020, the patient underwent endovascular treatment of a type b aortic dissection using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6), 2021, a distal migration (distance unknown) and a distal stent graft-induced new entry(dsine) were observed.On (b)(6), 2021, a reintervention placing additional gore® tag® conformable thoracic stent grafts with active control system was performed.The patient tolerated the procedure.It was reported that the device migrated since some space was created due to the dissociation.
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Manufacturer Narrative
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Additional information: b5: event description.
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Search Alerts/Recalls
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