Events

Rappel de HeartMate 3 Left Ventricular Assist 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 Abbott.

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
    79893
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1774-2018
  • Date de mise en oeuvre de l'événement
    2018-04-05
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163823
  • 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
    Ventricular (assist) bypass - Product Code DSQ
  • Cause
    Reports of outflow graft twist occlusions. patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
  • Action
    Customers were notified via an Important Medical Device Advisory letter, dated 04/05/2018, that the firm has received reports of outflow graft twist occlusions in the HeartMate 3 (HM3) Left Ventricular Assist System. As a result, patients whose devices experience this issue will experience a persistent low flow alarm. Outflow graft twist occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Physicians managing patients that will be implanted or already implanted with HM3 devices should follow the recommendations provided in the letter. Additionally, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case. Questions should be directed to customers' local Abbott MCS Clinical Specialist or MCS HeartLine 1-800-456-1477.

Device

HeartMate 3 Left Ventricular Assist System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 || Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Adresse du fabricant
    Abbott, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA