A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.
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The following was reported to gore from a retrospective study: on (b)(6) 2020, this 65 year-old patient underwent endovascular treatment for a pararenal aneurysm.Patient was treated with a cook custom branch device and five gore® viabahn® vbx balloon expandable endoprostheses (vbx-devices) to the celiac trunk, superior mesenteric artery, right renal artery, left renal artery and left accessory artery.The vbx-devices were successfully navigated to the intended location and successfully deployed.Device catheters were successfully removed.The devices were noted as patent at the end of the procedure.The patient was noted to have an endoleak type iiic in the left renal artery and left accessory renal artery on (b)(6) 2020.This resulted in prolonged hospitalization and endovascular reintervention.Endovascular reinterventions in the left renal artery and left accessory renal artery occurred on (b)(6) 2020, in which each an advanta v12 stent was placed.The devices were patent at the end of the procedure.
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