W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Catalog Number BXA095902A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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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.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b20 (h3): device remains implanted; therefore direct product analysis was not possible.No intervention was reported and patient is reported to be asymptomatic.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) 2021, the study patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) in the (b)(6) tambe pivotal study.Implanted branch devices were gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).One vbx device was implanted in each visceral vessel (left renal, right renal, celiac, and superior mesenteric artery.On (b)(6) 2023, cta imaging from third party revealed a wire fracture of the celiac artery side branch component on the distal end within the celiac artery.It was reported multiple rows appear to be impacted.All visceral vessels were patent, including the celiac artery at this time.No action was needed for the observed fracture.Patient appears to be asymptomatic.
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Manufacturer Narrative
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Images from third-party were received and reviewed: from the pivotal aaa 17-01 (tambe) clinical study, this complaint reports wire fracture of a vbx device observed through post-implantation follow-up imaging.No reduction in flow through the vbx device or other impact to the patient was reported in association with the reported fracture.Clinical images of the vbx device were available from multiple time points.No vbx device irregularities were noted in evaluation of images from (b)(6) 2022 (6 month post-implantation follow-up).However, evaluation of the clinical images from (b)(6) 2023 (24 month post-implantation follow-up) identified gaps/irregularities in the vbx device wire pattern which are indicative of strut fracture, though no broken wire surfaces were observed directly.While evaluation of the images provided indicates strut fracture of the vbx device at some time between when the 6 and 24 month post-implantation follow-up images were captured, neither the specific timing nor mechanism of the damage could be identified.Therefore, the root cause of the vbx device strut fracture could not be established with the information available.
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Search Alerts/Recalls
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