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 18 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 2015, using 80 protégé rx self-expanding peripheral and carotid stent systems and 70 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: 25 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 30 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 25, 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: 25 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 25 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: arteriovenous fistula (2 patients), arrhythmia (5 patients), artery dissection, flap, perforation or rupture (2 patients), bleeding from anticoagulant or antiplatelet medications(5 patients), cerebral ischemia, or transient ischemic attack (tia) (2 patients), contrast media reaction or renal failure (4 patients), embolism (2 patients), hematoma (10 patients), myocardial infarction (1 patient), pseudoaneurysm (14 patients), and stroke (2 patients).Events such as partial stent deployment (6 patients), restenosis of the stented segment (12 patients), stent collapse or fracture (4 patients), surgical or endovascular intervention (10 patients), thrombosis or occlusion of stent (9 patients) are reported as being associated with pta and stent placement.Reported complications with carotid interventions are reported as hypotension or hypertension (20 patients), pain (head, neck) (12 patients), severe unilateral headache (12 patients), and slow or no flow during procedure (6 patients) 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: allergic reaction to device materials or procedure medications (8 patients), aneurysm (5 patients), artery dissection, flap, perforation or rupture (8 patients), bleeding from anticoagulant or antiplatelet medications (15 patients), bleeding (with or without transfusion) (15 patients), congestive heart failure (chf) (15 patients), contrast media reaction or renal failure (6 patients), fever (12 patients), hematoma (15 patients), hypertension or hypotension (20 patients), inflammation (8 patients), ischemia or infarction of an organ or tissue (5 patients), pseudoaneurysm (8 patients), sepsis (5 patients), venous thromboembolism (2 patients).Complications of: abrupt or subacute closure (5 patients), allergic reaction implant (due to allergy to nickel titanium ¿ nitinol) (1 patient), gastrointestinal bleeding due to anticoagulation (5 patients), renal insufficiency (new or worsening) (6 patients), renal failure requiring dialysis (3 patients), restenosis of the stented segment (8 patients), stent misplacement (2 patients), surgical or endovascular intervention (6 patients), thrombosis or occlusion of stent (3 patients), and vessel spasm or recoil (4 patients) have been reported as being associated with pta and stent placement.The following complications are reported for biliary interventions: duct rupture resulting from overstretching the duct (1 patient) and infection (for biliary placement, secondary to contamination of the stent led to cholangitis, hemobilia, peritonitis, or abscess) (5 patients).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.
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