It was reported to gore that on (b)(6) 2023, the patient was implanted with gore® acuseal vascular graft (avg) in the forearm for dialysis.The hemodialysis access was utilized to perform dialysis puncture three times a week after surgery.On (b)(6) 2023, it was found graft stenosis at anastomosis and graft delamination on puncture site.The physician performed balloon dilation on the layered area of avg, and implanted additional stent.The patient tolerated the procedure and in good condition.
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H3: other - device was still implanted, therefore, it couldn't be returned for evaluation.H6: due to an unknown lot/serial number and no device return, an investigation could not be performed.Neither clinical images enabling direct assessment of product performance, nor the product was returned for evaluation.Cbas® 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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