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 TGM262615J |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation findings code c21: conclusions pending results of engineering evaluation.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 was reported to gore: on (b)(6) 2024, the patient underwent an endovascular treatment of an iatrogenic type b dissection using a gore® tag® conformable thoracic stent graft with active control system.After the gore® tag® conformable thoracic stent graft with active control system was inserted, while advancing to the implant site, a large amount of a blood leakage (amount unknown) from the delivery catheter, near the joint section between handle and catheter.The gore® tag® conformable thoracic stent graft with active control system was deployed in a hurry.During the secondary deployment of the gore® tag® conformable thoracic stent graft with active control system, it moved distally 8mm.No branch vessel obstruction occurred due to this device move.No ballooning was performed, and it was confirmed there was no endoleak and the procedure was concluded.The patient tolerated the procedure.No blood transfusion was required.The physician stated that a softer-than-normal wire was used for the deployment of the endoprosthesis since the patient had underwent tavr, and it is possible that the stent graft migration during the deployment occurred because the wire could not be pushed enough into the curvature.
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Search Alerts/Recalls
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