A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: other code: the medical device is available, but was not returned for further investigation yet.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.Further investigation is being conducted and will be included in the final report.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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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It was reported to gore that the patient underwent endovascular treatment for a popliteal aneurysm on the left leg with a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device).It was stated that the first vsx-device reached the lesion by using a 0.035 non stiff standard terumo guide wire.It was noticed that the delivery catheter bended in the popliteal region and when the physician tried to deploy the device, the system was blocked around the middle of the stent during the first step of deployment.The physician removed the vsx-device without any problems, used a new device with a stiff guide wire and performed the case successfully.There was no report of patient harm.
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