Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the protégé peripheral stent systems (the gps self-expanding peripheral and biliary stent system and the protégé rx self-expanding carotid stent system).Survey results from an interventional cardiologist in practice 12 years: physician has been using both protégé rx self-expanding peripheral and carotid stent system and protégé gps self-expanding peripheral and biliary stent systems since 2018, using 23 protégé rx self-expanding peripheral and carotid stent systems and 45 protégé gps self-expanding peripheral and biliary stent systems within the last year.The protégé rx self-expanding peripheral and carotid stent systems were used as follows: 12 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 5 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 6, to treat stenoses of the common carotid artery (cca), internal carotid artery (ica), and carotid bifurcation the protégé gps self-expanding peripheral and biliary stent system was used to treat: 20 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 10 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 15 palliative treatment of malignant neoplasms in the biliary tree.During use of the protégé rx self-expanding peripheral and carotid stent system, the following complications were encountered and associated with any percutaneous procedure: bleeding from anticoagulant or antiplatelet medications (3 patients), cerebral ischemia, or transient ischemic attack (tia) (1 patient), contrast media reaction or renal failure (5 patients), and hematoma (1 patient).Gastrointestinal bleeding due to anticoagulation (1 patient), renal insufficiency (new or worsening) (1 patient)and thrombosis or occlusion of stent (1 patient) are reported complications associated during pta and stent placement.Cerebral haemorrhage (1 patient), emergent or urgent endarterectomy surgery (cea) (1 patient), total occlusion of carotid artery (1 patient) are reported as complications associated with carotid interventions.During use of the protégé gps self-expanding peripheral and biliary stent system, the following complications were encountered and deemed associated with the percutaneous procedure: bleeding from anticoagulant or antiplatelet medications (1 patient), cerebral ischemia, or transient ischemic attack (tia) (1 patient), contrast media reaction or renal failure (1 patient), hematoma (1 patient).Gastrointestinal bleeding due to anticoagulation (1 patient) , renal insufficiency (new or worsening) (1 patient), and thrombosis or occlusion of stent (1 patient) are also reported during use of the protégé gps during pta and stent placement.Complication associated with biliary interventions is reported as duct rupture resulting from overstretching the duct which occurred in 1 patient.Of the above ae¿s reported for both the protégé rx self-expanding peripheral and carotid stent system, and the protégé gps self-expanding peripheral and biliary stent system; some of these are listed as having been previously reported to medtronic.Due to limited information these are included in reporting.
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