Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.Reference medwatch #2017233-2020-00244, and #2017233-2020-00247 for additional individual patient events within the article.
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The following article was reviewed: 'left ventricular assist device outflow graft obstruction - a complication specific to polytetrafluoroethylene covering.A word of caution!' talal alnabelsi, m.D.; alexis shafii, m.D.; john gurley, m.D.; kenneth dulnuan, m.D.; dwight harris, m.D.; maya guglin, m.D.; american society for artificial internal organs (asaio) journal: august 2019-volume 65 - issue 6 - p e58-e62; doi: 10.1097/mat.0000000000000929.The article discusses the evolution of left ventricular assist devices (lvads) and how they have changed the management of end-stage heart failure and the practice of heart transplantation.The article reports that polytetrafluoroethylene (ptfe) grafts have customarily been used to cover the outflow graft by surgeons to reduce adhesions and facilitate reentry sternotomy at the time of heart transplantation or left ventricular assist device (lvad) exchange.The article reports the presentation, diagnosis, and treatment of four cases of outflow graft obstruction because of formation of thrombus between the outflow graft and its protective ptfe cover.The patient presented with ischemic cardiomyopathy who underwent placement of a heartmate ii as a bridge to transplantation.An 18mm ptfe shield graft was placed around the outflow graft.Antithrombotic management was based on oral anticoagulation (coumadin) targeted to inr 2-3 and aspirin (81 mg/day).The patient presented 23 months after implantation with worsening fatigue.Computed tomography angiography (cta) of the chest indicated partial obstruction of the outflow graft proximal to the aortic anastomosis.The thrombus appeared to be located between the ptfe shield and outflow graft.The patient underwent four overlapping ld mega 12x36 stents resulting in immediate improvement of flows.He was discharged in stable condition after an overnight hospital stay and received a heart transplant 1 month following stenting of the outflow graft.
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