Events

Safety Alert for INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Boston Scientific Philippines, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-043
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488555-fda-advisory-no-2018-043-voluntary-recall-of-innova-180-mm-200-mm-self-expanding-stent-system
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-043 voluntary recall of innova™ 180 mm & 200 mm self-expanding stent system all are hereby advised by the food and drug administration (fda) about the voluntary recall of innovatm stent system with attached sizes distributed by boston scientific philippines, inc., with business address at unit 2503 antel global corporate center, julia vargas, avenue, ortigas center, pasig city 1605 with the following information: the cited medical device was voluntarily recalled by boston scientific philippines, inc. after partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. the most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. in certain cases boston scientific philippines, inc. received reports of major surgery to retrieve the stent/delivery system or to correct vascular compromise. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested.   attachments: fda advisory no. 2018-043.Pdf.

Device

INNOVA™ 180 mm & 200 mm SELF-EXPANDING STENT SYSTEM

Manufacturer

Boston Scientific Philippines, Inc.
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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
    FDAP