Medical device manufacturer, Cook Ireland Limited, has issued a field safety notice concerning Zilver PTX Drug-Eluting Peripheral Stent [Catalogue number: ZIV6*****PTX]
The manufacturer has received a number of complaint reports relating to the delivery system for the Zilver PTX Drug Eluting Stent (13 complaints with an occurrence rate of 0.043%; two occurrences were considered serious adverse events) involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. In December 2012, the manufacturer issued a Field Safety Notice (FSCA-identifier: 2012C0005) to customers advising of the potential risk of tip/inner catheter separation, but no root cause had been established at that time.
Since December 2012, the manufacturer has responded to complaint reports by carrying out an in-depth investigation to better understand the root cause and the risk to patients of these tip separations.
As a result of their investigation, the manufacturer is initiating a voluntary withdrawal as they have determined that there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. This withdrawal is intended to address the patient risks that may be associated with this potential occurrence.
This is a potential failure mode of the delivery system and does not affect the safety or efficacy of the implantable stent. Previously implanted stents are not affected by this withdrawal.
This notice relates only to the ZILVER PTX Drug Eluting Peripheral Stent delivery system. Any ZILVER FLEX and other bare metal stents from Cook Medical are not affected.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 April 2013