W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Catalog Number BXA117902E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2022 |
Event Type
Injury
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Event Description
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Reportedly on (b)(6) 2019, this patient underwent a 4-branched evar procedure + tevar, with cook as a main device.Gore® viabahn® vbx balloon expandable endoprostheses were implanted in the left and right renal arteries and superior mesenteric artery.Tc was left open as perfusion branch to the spine.The vbx implanted in the superior mesenteric artery was flared to 16 mm due to the big size of the artery.According to reports on (b)(6) 2022, the patient underwent computer tomography angiography.Prior to the examination, blood was collected for renal function examination.The physicians identified a decrease in the glomerular filtration rate, which indicates a potential loss of kidney function.However, the patient was asymptomatic.During the review of the cta images, the physician observed an occlusion of the vbx implanted in the right renal artery and subsequent filling of the aneurysm.The physicians believed that the vbx was broken.In (b)(6) 2022 the vbx in the superior mesenteric artery was relined with again with another vbx and the filling of aneurysm was excluded.Reportedly on (b)(6) 2023, the patient had another cta which confirmed no further filling of aneurysm.
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Manufacturer Narrative
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No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Additional information in regard to the event and images of the case were requested from the physician.The provided additional information is captured in the event description.A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Engineering evaluation could not be performed as the device remains.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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Manufacturer Narrative
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The manufacturing records for the device were reviewed and documented in the product history task.The device lot met all pre-release specifications.The product itself, which remains implanted, was not returned for evaluation.The device was reportedly flared to a diameter of 16mm which is the technical limit of the device as determined by in-vitro testing for the indicated use; device expansion beyond 13 mm was not studied as part of the vbx flex clinical study.Evaluation of the provided clinical image indicates blood flow through this stent at the time the image was taken.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) possible adverse events and complications that may occur with the use of the device or in any endovascular procedure and require intervention include, but are not limited to: endoleak and/or endotension.Corrected patient id.Updated physician's number.
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