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 radiologist in practice 11 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 2013, using 70 protégé rx self-expanding peripheral and carotid stent systems and 60 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: 10 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 40 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 20, 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: 10 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 30 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 20 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: arrhythmia (1 patient), bleeding (with or without transfusion), cerebral ischemia (2 patients) , or transient ischemic attack (tia) (1 patient), and myocardial infarction (2 patients).Events such as failure to deploy stent, partial stent deployment, restenosis of the stented segment are reported as being associated with pta and stent placement.An occurrence of pain (head, neck) in 1 patient is listed as associated with carotid interventions.During use of the protégé gps self-expanding peripheral and biliary stent system, the following complications are reported as deemed associated with the percutaneous procedure: arteriovenous fistula (1 patient), bleeding from anticoagulant or antiplatelet medications (1 patient), bleeding (with or without transfusion) (2 patients), embolism (1 patient), and intraluminal thrombus (2 patients).Complications of stent damage or entanglement and surgical or endovascular intervention have been reported as being associated with pta and stent placement.No complications are reported associated with biliary interventions.Of the above complications (adverse events) reported for the protégé rx self-expanding peripheral and carotid stent system and, protégé gps self-expanding peripheral and biliary stent systems some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.
|