Events

Rappel de Device Recall Lotus Valve System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69931
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0915-2015
  • Date de mise en oeuvre de l'événement
    2014-11-19
  • Date de publication de l'événement
    2015-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131993
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Cause
    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.
  • Action
    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.

Device

Device Recall Lotus Valve System
  • Modèle / numéro de série
    Serial numbers: 14113043, 14118011, 14118012, 14119047, 14119048, 14119049, 14119050, 14119051, 14120027, 14120028, 14120029, 14120030, 14120031, 14121035, 14121036, 14121037, 14121038, 14121039, 14121040, 14121041, 14125040, 14125041, 14125042, 14125043, 14125044, 14125045, 14125046, 14125047, 14125048, 14125049, 14127073, 14127077, 14127078, 14127079, 14127080, 14127081, 14127082, 14127083, 14127084, 14127085, 14127086, 14141044, 14141045, 14141046, 14141047, 14141048, 14141049, 14141050, 14141051, 14141052, 14141053, 14148034, 14148035, 14148036, 14148037, 14148039, 14153054, 14153055, 14153057, 14153058, 14153059, 14153075, 14153076, 14153077, 14153078, 14153079, 14157003, 14157015, 14157016, 14157017, 14157019, 14157020, 14157021, 14157022, 14157023, 14178024, 14178025, 14178026, 14178027, 14178028. Nov. 15, 2014 to Jan. 24, 2015.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
  • Description du dispositif
    Lotus TAVR 23mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV230, Catalog Number LTV23; || 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.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 160 Knowles Dr, Los Gatos CA 95032-1828
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA