Events

Rappel de Absorb Bioresorbable Vascular Scaffold (BVS) 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 Vascular.

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
    77131
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2151-2017
  • Date de mise en oeuvre de l'événement
    2017-04-26
  • Date de publication de l'événement
    2017-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155009
  • 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
    Absorbable coronary drug-eluting stent - Product Code PNY
  • Cause
    Abbott vascular is initiating a recall of the absorb bioresorbable vascular scaffold (bvs) system due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the xience metallic drug eluting stent.
  • Action
    Abbott Vascular sent an Urgent Medical Device Recall and Hazard Alert letter dated April 26, 2017, to affected customers to inform them that the action is in response to recent concerns over data from some studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent. Customers were informed of the actions to be taken. Customers were instructed to stop using these devices immediately, advise BVS patients to follow the recommendations for DAPT prescribed by their health care provider. Advise patients experiencing new cardiac symptoms to seek clinical care, review their inventory and complete the attached Facsimile Reply Form and display and share this notification with other relevant personnel within their organization. Customers with questions are instructed to contact their local Abbott Vascular Representative or Customer Service department.

Device

Absorb Bioresorbable Vascular Scaffold (BVS) System
  • Modèle / numéro de série
    Australia: Part No. Description 1012462-08 2.5 x 08 mm Absorb BVS 1012462-12 2.5 x 12 mm Absorb BVS 1012462-18 2.5 x 18 mm Absorb BVS 1012462-23 2.5 x 23 mm Absorb BVS 1012462-28 2.5 x 28 mm Absorb BVS 1012463-08 3.0 x 08 mm Absorb BVS 1012463-12 3.0 x 12 mm Absorb BVS 1012463-18 3.0 x 18 mm Absorb BVS 1012463-23 3.0 x 23 mm Absorb BVS 1012463-28 3.0 x 28 mm Absorb BVS 1012464-12 3.5 x 12 mm Absorb BVS 1012464-18 3.5 x 18 mm Absorb BVS 1012464-23 3.5 x 23 mm Absorb BVS 1012464-28 3.5 x 28 mm Absorb BVS
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Australia
  • Description du dispositif
    Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). || The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Adresse du fabricant
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • 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