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.
데이터 추가 비고
Mitral valve repair devices - Product Code NKM
원인
Abbott vascular has recently received reports of cases on clip delivery system devices that contain the one-way actuator knob where a user attempted implanting a mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture.
조치
The firm, Abbott Vascular, sent an "URGENT FIELD SAFETY NOTICE/MITRACLIP/CORRECTION" letter dated 2/4/16 to all the customers who received the MitraClip System. The letter described the product, problem and actions to be taken. The Customers are informed that their inventory is acceptable for safe use following the revised IFU steps described in the customer notification letter and that there is no need for the customers to return any product to Abbott Vascular. Customers with questions are instructed to contact their local Abbott Vascular representative.Customers were also instructed complete and return a Training Form/Effectiveness Check via their Abbott Vascular Representative, fax to 1-951-914-5951 or scan and email to AVRegulatoryCompliance@av.abbott.com. The firm is revising the IFU to incorporate the revised procedural steps.
A press release dated 2/26/16 will be posted on the firm's website to inform the public that Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device.
Customers with questions or concerns are instructed to contact Abbott Vascular Representative or call Abbott Vascular at (800) 227-9902.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
제품 설명
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System || contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. || The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.
“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.