W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
|
Back to Search Results |
|
Catalog Number TGU454515J |
Device Problem
Patient-Device Incompatibility (2682)
|
Event Date 04/27/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
B3: the actual event date s unknown, therefore 27-apr-2018 is used as the event date.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.
|
|
Event Description
|
The following was reported to gore: on (b)(6) 2018, the patient underwent an endovascular treatment of a proximal type i endoleak from a non-gore stent graft.A gore® tag® conformable thoracic endoprosthesis was implanted in almost same place with the previously implanted non-gore stent graft to treat the endoleak.On an unknown date, it was observed the proximal type i endoleak remained.An ascending aorta replacement and total debranching were performed to treat the proximal type i endoleak.The patient tolerated the procedure.
|
|
Manufacturer Narrative
|
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Emdr section h6, codes c21 and d16 are removed and c19, d15 and d12 are added to reflect results of investigation.H6: code d12: according to the gore® tag® conformable thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak.
|
|
Search Alerts/Recalls
|
|
|