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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Following information was reported to gore: first gore® viabahn® endoprosthesis with heparin bioactive surface was deployed as usual (distally in the cfa) then, the second viabahn® endoprosthesis device was deployed (overlapping with the first one and into common iliac artery).After the deployment, a radiopaque marker that was not common was noticed in the image.The olive of the deployed second viabahn® endoprosthesis device catheter was detached and migrated distally.This olive ended distally in the profunda femoral artery impacted to a calcium plaque.This problem was on one gore® viabahn® endoprosthesis with heparin bioactive surface only but, both are reported as it is unknown which device was effected (stickers are always kept together and placed at the end of the procedure).Two images were received and reviewed by imaging showing: the.Jpg images provided for evaluation show that the olive tip appears to be separated and has migrated distally.There are no patient identifiers on the images.
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