It was reported through a research article that patient presented with anterior st-elevation myocardial infarction with chest pain.During the percutaneous coronary intervention, a 3.0 x 33 mm xience sierra stent was implanted in the left anterior descending artery (lad), with the proximal stent struts protruding into the ostium of the circumflex artery.Several days later, during a staged procedure to the obtuse marginal (om) artery, a 2.5 x 38 mm xience sierra stent attempted to cross the recently implanted stent in the lad, but resistance was felt, so the 2.5 x 38 mm xience sierra stent system was retracted, but dislodged and was entangled with the lad stent.Both stents became stretched.A snare was used to remove the om stent, but because it was entangled with the lad stent, removal of the om stent resulted in removal of the lad stent and dissections in the lad and distal left main.The arteries were re-wired and new stents were successfully implanted.Results were excellent.Please see article (case 2) for additional information.
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Date of event estimated.The device was not returned for analysis.A review of the lot history record and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effect of dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the advancing device interacted with the previously implanted stent causing the reported failure to advance.During retraction continued interaction caused the reported stent stretching, material deformation with the patient effect of dissection.The continued interaction with the implanted stent resulted in the reported dislodgement from the delivery system and removal of the implanted stent.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device is filed under a separate medwatch report number.Literature attachment.Article title ¿case series of iatrogenic coronary stent avulsion: a rare complication with varied management strategies.¿ (case 2).
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