Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.
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https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2022