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 15 years: physician has been using both protégé rx self-expanding peripheral and carotid stent system since 2013, using 30 protégé rx self-expanding peripheral and carotid 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) and 5 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries.During use of the protégé rx self-expanding peripheral and carotid stent system, the following complications were encountered and associated with percutaneous procedure: pseudoaneurysm (2 patients).Restenosis of the stented segment is reported to have occurred associated with pta and stent placement in one patient and is reported as an unexpected event.An emergent or urgent endarterectomy surgery (cea) associated with carotid intervention is also reported for 1 patient as an unexpected event.All complications (adverse events) encountered were reported as being not device related at all.
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