Events

Recall of Absorb Bioresorbable Vascular Scaffold (BVS) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77131
  • Event Risk Class
    Class 1
  • Event Number
    Z-2151-2017
  • Event Initiated Date
    2017-04-26
  • Event Date Posted
    2017-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155009
  • Notes / Alerts
    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.
  • Extra notes in the data
    Absorbable coronary drug-eluting stent - Product Code PNY
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Australia
  • Product Description
    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
  • Manufacturer Address
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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