W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
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Catalog Number JHJR060202J |
Device Problems
Complete Blockage (1094); Device Stenosis (4066)
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Patient Problems
Obstruction/Occlusion (2422); Restenosis (4576)
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Event Date 03/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Device remains implanted; therefore, direct product analysis was not possible.Code c20: device lot/serial number was requested but not made available.Ifu for gore® viabahn® endoprosthesis with heparin bioactive surface state: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.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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Event Description
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On (b)(6) 2020, a study patient underwent an endovascular treatment for venous anastomosis occlusion and recoil of an arteriovenous graft located in the left basilic vein using a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).As reported, this patient had previous interventions with implantation of non-gore device(s) at the vascular access site, prior to the viabahn device implant.The patient tolerated the procedure.On (b)(6) 2022, thrombus occlusion and edge stenosis were identified by angiography.On the same day, intervention included re-stenting with an additional viabahn device.On (b)(6) 2022, decreased thrill was noted.Along with other devices, the viabahn device implanted march 10, had occluded with thrombus.On the same day, surgical thrombectomy was performed.As reported, no significant stenosis was observed in the access circuit by angiography during the procedure.The event was resolved, and the patient tolerated the procedure.
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Manufacturer Narrative
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D4: catalog number was obtained and entered into appropriate field.
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Search Alerts/Recalls
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