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Model Number UNK-CV-SR-VAL-CAP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Rupture (2208); Paraplegia (2448); Vascular Dissection (3160)
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Event Date 04/03/2023 |
Event Type
Injury
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Event Description
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Valiant captivia stent grafts were implanted in 200 patients in the endovascular treatment of type b aortic dissections on unknown dates over a 10 year period.In this group there were 24 cases of complicated type b aortic dissections which among them 8 had aortic rupture, 12 had malperfusion including celiac (1), superior mesenteric (5), renal (3), and iliofemoral (5) arterial distributions.3 had refractory hypertension, and 1 had persistent pain. the safety and efficacy of the valiant captivia was compared with outcomes from the other cohort of patients (100) who were implanted with a non mdt stent grafts. the following malfunctions were reported : type ia endoleak, ib endoleak, false lumen perfusion the following adverse events were reported; sine, stroke, paraplegia, rupture and re-intervention patient mortality was reported and a patient death was attributed to a malfunction of a valiant captiva stent graft.
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Manufacturer Narrative
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G2: citation: authors: le mao 1, jingyang luan 2, yimin yang 2, yi si 2, yuanqing kan 2, tianyue pan 2, ting zhu 3, weiguo fu 4.The efficacy and safety of gore conformable thoracic stent graft and valiant captivia thoracic stent graft for acute type b aortic dissection.International journal of cardiology 2023.Doi: 10.1016/j.Ijcard.2023.03.060.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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