No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Code (b)(4).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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Reportedly on (b)(6) 2022, this patient underwent an endovascular treatment for an occlusive peripheral vascular disease in which a gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the right superficial femoral artery.The procedure type was recorded as percutaneous transluminal angioplasty, vascular access was successfully gained through the right common femoral artery, the device was successfully navigated and deployed in the intended location.The delivery catheters were successfully removed and the patency of the vbx was confirmed at the end of the procedure.On (b)(6) 2022, an adverse event termed "right limb not patent" was reported and an intervention was performed.The subject didn't have any undocumented adverse events since the last visit.According to reports, the vsx device was confirmed as non patent.
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