—#131995

Product

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.

FDA product code: NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Boston Scientific notified consignees on November 19, 2014, of the problem via letter through overnight delivery directing consignees to segregate and return affected product to Boston Scientific utilizing the Field Safety Corrective Action (FSCA) Instructions provided. The FSCA details that consignees should: Immediately discontinue use of and segregate product; Complete and return the Account Reply Verification Tracking form and Package/Ship the affected product.

Recalling firm

Firm: Boston Scientific Corporation
Address: 160 Knowles Dr, Los Gatos, California 95032-1828

Distribution

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

Timeline

Recall initiated: 2014-11-19
Posted by FDA: 2015-01-13
Terminated: 2015-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.