W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number PAJR062502E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 01/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: device whereabouts unknown, information requested.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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Physician used sheath 6fr 45cm cross over.Failure of recanalization via anterograde punction with guidewire connect 250, halberd et astato with cxi0.018.So he creates a retrograde punction via tibial.He uses a guidewire 0.014 command es with trailblazer 0.014.He obtains a "meetic point ", he creates a mini incision on fsa.Predilatation with balloon 0.018 6x150.He introduces the viabahn 6mmx250mm.For the deployment, the proximal part didn't open and impossible to retry the shaft.Finally, the shaft is replied but it was incomplete.A piece of the shaft extracted when the surgeon retry the guidewire realized the telpeheric.Finally the patient is treated with another devices.By the 30th, it was necessary to operate the patient because feelings syndrome cold feet and occlusion.So the physician decides to do a bypass with saphenous vein.After the bypass, he realized a control for the distal anastomosis via angiography, he saw that it wasn't flux in the tpp.So he decides to open surgery this area and he saw a piece of the viabahn shaft.It blocked the tpp.He retried the piece and after that, the flow was nice in this area.
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Search Alerts/Recalls
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