The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.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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It was reported, the physician implanted a 32mm gore® cardioform asd occluder on (b)(6) 2020, to close an atrial septal defect (asd).The patient had a stroke in (b)(6) 2023 and two more in (b)(6) 2023 while on asa and eliquis.A transesophageal echocardiography on (b)(6)2023 showed "thickening as well as a possible 3 x 2 mm mobile mass visualized in the posterior aspect of the device in the left atrium, differential includes fibrous thickening versus thrombus".On (b)(6) 2023 the patient had the device surgically removed and the asd and left atrial appendage closed surgically.The patient was doing well following the procedure.
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