W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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Catalog Number PAJ050502 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 07/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the device remains implanted, a further investigation on the device cannot be performed.The author was contacted to ask for further details like event date, serial no., implant date as well as possible root cause.Date of event was determined as date when literature article was published, here (b)(6) 2020.As patient age (b)(6) was determined and as gender male as mentioned in the article.Cbas¿ heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Event Description
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The following literature was reviewed: preliminary experience using a covered stent graft in patients with acute ischemic stroke and carotid tandem lesion" published by carlos pinana et al.In cardiovascular & interventional radiology 2020;43(11):1679-1686.The study reviews the use of a covered stent graft (gore¿ viabahn¿ endoprosthesis with propaten bioactive surface) for patients with acute ischemic stroke (ais) and tandem lesions in a high-volume comprehensive stroke center in a real-life scenario.A retrospective review of all patients that underwent carotid endovascular interventions during mechanical thrombectomy for ais using a self-expanding covered stent graft at vall dhebron university hospital between 2016 and 2018 was conducted.Patient clinical and angiographical characteristics as well as postoperative outcome and follow-up were recorded.A total of eight patients were treated with the covered stents.As post-procedural complications a high level of occlusion at three-month follow-up was found.The stents of five patients (patient 2, 3, 4, 5 and 6) were occluded, although the patients did not show signs of stroke recurrence.This case represents patient 6.
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Manufacturer Narrative
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D4; catalog number, serial number, expiration date and unique identifier was updated.The author came back and stated the following comment: wake up stroke, initial moderate-low aspects, non candidate to iv rtpa.After successful reperfusion bad hemodynamics persist due to stenotic extracranial ica and stenting was decided.Antiplatelets withheld until control ct scheduled for 12 hours after the procedure, although urgent mri was performed the same day after early neurologic deterioration, depicting a major ischemic lesion.A review of the manufacturing-, sterilization- and heparin coating records will be performed.
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Manufacturer Narrative
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H6 evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted in the patient, therefore a device evaluation could not be performed.The information reported in the complaint, including reference patient clinical information did not add relevant information to further the device functionality investigation.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.
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