H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.H3: other: imaging evaluation summary.The imaging evaluation performed by a clinical imaging specialist showed the following: four timepoints submitted for evaluation.Pre-implant cta dated (b)(6) 2023: lci length measures ~ 66.3 mm.Length to the bifurcation in the liia measures ~ 30 mm, calcium present.Procedural angiogram dated (b)(6) 2023: final angiogram not available for review post implant cta dated (b)(6) 2023: liia is patent.Post implant cta dated (b)(6) 2023: shows an occlusion within the device and lack of wall apposition near the distal end of the stent, calcium present.Length of the occlusion measures ~ 6.1 cm.Able to confirm device occlusion and lack of circumferential wall apposition.According to the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events that may occur and / or require intervention include but are not limited to occlusion of device or native vessel and claudication (e.G., buttock, lower limb).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: on (b)(6) 2023, the patient underwent a successful endovascular aneurysm repair (evar) procedure with left ibe placement (gore® excluder® iliac branch endoprosthesis).On (b)(6) 2023, the 1 month follow up cta was unremarkable and looked good.On (b)(6) 2023, the recent 6 month follow up cta revealed an occluded left internal iliac limb of the ibe device.There was distal collateral flow in the left internal iliac artery.In speaking with the physician, the patient did complain of non-lifestyle limiting buttock claudication at the 1 month follow up.This has not changed in severity with failure of the limb.On (b)(6) 2023, the physician notified the field sales associate (fsa) of this failure in passing.In the review of the images, there is chunk of calcium in the left internal iliac artery at the distal edge of the limb.This appears to keep the limb from fully apposing the vessel and may be the reason for the failure.No treatment will be performed at this point in time.
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