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.The following information was requested but was not made available-patient name/initials, weight, date of birth, pre-existing conditions and medications.The device lot/serial number/udi information remains unknown.The lot serial number for the device outlined in this event was not provided, therefore the manufacturing date remains unknown.Code 4117, device not accessible for testing - the medical device was discarded at the treating facility and is therefore not available for evaluation.According to the gore® dryseal flex introducer sheath instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, vascular trauma such as dissection.Furthermore, the gore® dryseal flex introducer sheath ifu states that careful evaluation of vessel size, tortuosity, and disease state is required to ensure successful sheath introduction and subsequent withdrawal.If the vessel is not adequate for access, vessel damage may result.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient may result.
|
The following information was reported to gore: on (b)(6) 2022, this patient underwent an emergency endovascular treatment for a ruptured thoracic aneurysm using gore® dryseal flex introducer sheath as an accessory during the procedure.A 20 fr sheath was inserted from the right side of the patient.After the stent graft implantation, angiography confirmed the right iliac artery rupture.For treatment of the iliac rupture, 2 gore® viabahn® vbx balloon expandable endoprosthesis were implanted in the right external iliac artery.The patient tolerated the procedure.Reportedly the access vessel was narrow.
|