Events

Safety Alert for EnVeo R Loading System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

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
  • Date
    2015-07-16
  • Event Date Posted
    2015-07-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150716_1.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic enveo r loading system medical device manufacturer, medtronic, has issued a medical device safety alert concerning enveo r loading systems for specific lot numbers of model numbers due to particulate being observed in a small number of cases. the affected devices are identified as follows: model numbers: ls-enveor-23, ls-enveor-2629, ls-enveor-23-c, ls-enveor-2629-c lot numbers: 0007266413, 0007408862, 0007462905, 0007515698, 0007573785, 0007332504, 0007408865, 0007476215, 0007515700, 0007573788, 0007332506, 0007408867, 0007476217, 0007515703, 0007573791, 0007332508, 0007408869, 0007476219, 0007522595, 0007579940, 0007332510, 0007428258, 0007482219, 0007522598, 0007579944, 0007343321, 0007428260, 0007482222, 0007522600, 0007579948, 0007343324, 0007428263, 0007482226, 0007522603, 0007579951, 0007343327, 0007435169, 0007486826, 0007530963, 0007592664, 0007350825, 0007439358, 0007492356, 0007530973, 0007592666, 0007350837, 0007439360, 0007495691, 0007537892, 0007592669, 0007354245, 0007439362, 0007495694, 0007537894, 0007592672, 0007366949, 0007456292, 0007495696, 0007569474, 0007598984, 0007369883, 0007456298, 0007508883, 0007569477, 0007254814, 0007393098, 0007462901, 0007508885, 0007569482, 0007354113, 0007393101, 0007462903, 0007508891, 0007573778 through 6 july 2015, the manufacturer has received eight reports related to this issue out of 7,347 potentially affected units. two were reported as particulate being observed in packaged kits and six were reported as particulate being observed in the loading bath during valve loading. according to the manufacturer, presence of particulate in the enveo r loading system has the potential to be transferred to the transcatheter aortic valve (tav) and released into the patient’s vasculature after deploying the tav. if this were to occur, potential harms may include embolism into the bloodstream. the manufacturer advises customers to immediately quarantine the unused potentially affected product form their inventory and return them to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 july 2015.

Device

EnVeo R Loading System
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: Medtronic EnVeo R Loading System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH