The following information was reported to gore: on (b)(6) 2019, due to a clinically diagnosed arm swelling (caused by stenosis) this patient underwent a luminal reconstruction for an arteriovenous fistula in which a gore® viabahn® vbx balloon expandable endoprosthesis was implanted in the subclavian vein.Reportedly, the whole procedure was uneventful, vascular access was successfully gained through the cephalic vein, device was deployed as intended, catheters were successfully removed and the patency of the devices were confirmed at the end of the procedure.Reportedly on (b)(6) 2019, an adverse event termed "intrastent stenosis (proximal inside the vbx stent)" was discovered which lead to preventative medical and surgical intervention.The primary relationship of the adverse event to the vbx was indicated as study device related.
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No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Evaluation of the device couldn't be performed because the device remains implanted.The physician has been contacted to provide additional information regarding the reported adverse events.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.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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