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 a vascular surgeon in practice 20 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 2017, using 27 protégé rx self-expanding peripheral and carotid stent systems and 19 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: 7 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 11 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 9, 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: 6 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 8 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 5 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: artery dissection, flap, perforation or rupture (1 patient), bleeding from anticoagulant or antiplatelet medications (4 patients), cerebral ischemia, or transient ischemic attack (tia) (2 patients), hematoma (3 patients), intraluminal thrombus (2 patients), venous thromboembolism (1 patient).Partial stent deployment (1 patient), stent collapse or fracture (1 patient), stent misplacement (1 patient), thrombosis or occlusion of stent (1 patient), vessel spasm or recoil ( 2 patients) are reported complications associated during pta and stent placement.Hypotension or hypertension (2 patients), pain (head, neck) (3 patients), severe unilateral headache (3 patients), slow or no flow during procedure (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: aneurysm (1 patients), arrhythmia (4 patients), artery dissection, flap, perforation or rupture (1 patient), bleeding from anticoagulant or antiplatelet medications (3 patients), hematoma (3 patients).Stent migration (1 patient), 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 infection (for biliary placement, secondary to contamination of the stent led to cholangitis, hemobilia, peritonitis, or abscess) which occurred in 2 patients.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.
|