W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGU312610J |
Device Problem
Patient-Device Incompatibility (2682)
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Event Date 11/14/2015 |
Event Type
Injury
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Manufacturer Narrative
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H3: code "other" was selected as the medical device remains implanted.Return not possible.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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The following information was reported to gore: on (b)(6) 2015, this patient underwent endovascular treatment for a thoracic type b dissection using conformable gore® tag® thoracic endoprostheses.An angiography determined the proximal type i endoleak after deployment.As it was a small amount, no further treatment was given.The patient was placed under observation.On an unknown date, a follow-up ct determined an enlargement of the thoracic aortic aneurysm.Embolization was performed using nbca.On an unknown date, an additional procedure was planned due to an aneurysm enlargement of the distal side of the device and a distal type i endoleak.On (b)(6) 2024, the patient underwent reintervention for an aneurysm enlargement and a distal type i endoleak using gore® tag® conformable thoracic stent graft with active control system.After deployment, the proximal side of the device appeared to be distorted when they adjusted the angulation control.Additional stent grafts were implanted on the proximal side as a treatment.Physician¿s comment: i tried to move the device (tgmr313115j) distally to fit it under curvature by angulation control, but it was placed in an unexpected position.
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Manufacturer Narrative
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H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Emdr section h6, codes b14, c19, d12, d15 updated to reflect results of investigation.H6: code d12: according to the conformable gore® tag®thoracic endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion).
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Search Alerts/Recalls
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