Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Inferior Vena Cava Filter Sets. The products are identified as follow:

• A) Gunther Tulip Vena Cava Filter Set; B) Cook Celect Vena Cava Filter Set; C) Cook Celect Platinum Vena Cava Filter Set.
• Catalogue Identifier: IGTCFS-65-1/2-FEM/JUG/UNI-TULIP/CELECT/CELECT-PT

The manufacturer is informing users about a global implementation of updated Cook Inferior Vena Cava (IVC) Filter product labeling from 25 February 2019. The labeling updates are being made to ensure physicians are appropriately informed so to make the best decisions regarding patient care and are not related to feedback questioning device safety or performance. The updates are based on the most updated information available from post-market surveillance, data published in international standards and regulatory communications, and updated clinical data pertinent to the products. The added information is not reflective of a change in risk profile of the devices but is in line with common product safety knowledge.

According to the manufacturer, the changes impact the device labels and the following sections of the Instructions for Use (IFUs): Device Description, Intended Use, Contraindications, Warnings, Precautions, MRI Safety Information, Potential Adverse Events, Clinical Studies, step-by-step Instructions for Use, and References. Updates are made to the patient card to reflect changes in the MRI Safety Information section of the IFUs.

The IFU for each Cook IVC filter continues to highlight the importance of individual risk-benefit patient evaluation by Healthcare Professionals (HCPs). Likewise, the IFUs continue to emphasize the importance of routine follow-up and IVC Filter retrieval when clinically indicated.

The affected users are advised to take the following actions:

• No retrospective action for previously implanted products is warranted; however, compliance with current routine follow-up guidance is recommended.
• Read and understand the new IFU to ensure full comprehension of the product's intended use.
• The electronic versions of the IFUs can be found on the manufacturer's website by Catalogue Number search.
• The manufacturer's representative will personally follow-up and provide corrected IFUs for their inventory.

According to the local supplier, the affected products are distributed in Hong Kong

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 26 February 2019