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Device Problem
Use of Device Problem (1670)
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Patient Problem
Death (1802)
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Event Type
Death
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Manufacturer Narrative
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On completion of the investigation a follow up report will be submitted.
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Event Description
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Article received: gibello, l.E.(2020).Current results of balloon expandable visceral stent-grafts in fenestrated endografting.Journal of cardiovascular surgery, 37-46.Purpose: the purpose of this systematic review is to analyze the results of currently used balloon expandable bridging stent-grafts and to evaluate the newest developments for fenestrated endovascular aortic repair (fevar) in juxtarenal endovascular repair.Method: data was retrieved from retrospective analyses, case series and case reports conducted from 2000 to september 2019.Conclusion: the better understanding of the system fevar-native aorta, the strict collaboration and exchange of expertise between physicians and engineers and the consequent improvement of graft flexibility and resistance could really increase the performances of the bridging stent-graft and reduce reinterventions and complications in fevar.Per the article deaths occurred within the study period.
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Manufacturer Narrative
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This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Conclusion: note: the use of the device may be related to an off-label use of the icast¿ balloon expandable covered stent, which means that the use has not been approved or cleared by the food and drug administration (fda) as safe or effective.Getinge¿s icast¿ covered stent is fda 510(k) cleared for the treatment of tracheobronchial strictures produced by malignant neoplasms.Considering the design of the study as retrospective systematic review of scientific publications with some data adjudicated by investigators, high technical success rate of icast/advanta v12 stents, high primary patency rate, excellent freedom from branch instability and low mortality rate, one can infer that getinge¿s icast/advanta v12 balloon expandable covered stents performed as expected.The authors do not attribute development of complications to any particular stent type.H3 other text : product not available.
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Event Description
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N/a.
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Search Alerts/Recalls
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