Literature citation: endovascular stenting in the management of malignant superior vena cava obstruction: comparing safety, effectiveness, and outcomes between primary stenting and salvage stenting, hong kong med j , volume 21 number 5, october 2015.Device evaluated by manufacturer: the device was not received for analysis.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
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Reported via journal article that within this study, it was reported that haemopericardium occurred.Wallstent endoprostheses were used in all patients in this study to compare the safety, effectiveness, and outcomes of primary stenting and salvage stenting for malignant superior vena cava obstruction.Intravenous heparin was administered before stent placement.Pre-procedure superior vena cavograms were performed for assessment of site, length, degree of stenosis, and planning of stent placement.The stenoses were first negotiated with a guidewire.Placements of wallstents across the stenoses were then performed.Balloon angioplasty was performed before and/or after stent placement if considered necessary by the performing interventional radiologist.Stent position and patency were confirmed by post-procedural superior vena cavogram.Procedure-related complications included haemopericardium, acute pulmonary oedema and bleeding- related complications, groin haematoma, arterial.One periprocedural death occurred due to fatal haemopericardium.
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