Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.

Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.

Code information: Serial numbers: 14076030, 14076031, 14079012, 14079013, 14149023, 14149031, 14149038, 14149040, 14150028, 14150029, 14153080, 14153081, 14153082, 14154040, 14157024, 14157025, 14157026, 14157027, 14157029, 14157030, 14157031, 14157032, 14157033, 14165041, 14165042, 14165043, 14165044, 14175039, 14175040, 14175041, 14175042, 14175043, 14175044, 14175045, 14175047, 14178019, 14178020, 14198066, 14198067, 14198068, 14198069. Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.

Distribution pattern: Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.