Alert against batches of peripheral stents of US co
| Date :07-Jul-2022 |
By Rajendra Diwe
‘Cordis’, a multinational giant company manufacturing and supplying stents across the world, has recalled the two specific sizes of the Palmaz Genesis Stent on OPTA PRO.035 delivery system that were produced during October 2019 to April 2021. The decision to recall the product has been taken by the company after witnessing an increased trend in complaints for stent dislodgment and associated failure modes related to these specific sizes. Taking a note of Distributed Risk Assessment Form submitted by Cordis, the Central Drug Standard Control Organisation (CDSCO) has issued a medical devices alert. The alert has been issued on certain batches of peripheral stents manufactured by US-based medical technology firm Cordis following the company raised alarm due to increasing complaint rate for the product. “An alert has been issued on Cordis Palmaz Genesis peripheral stent on Opta Pro .035 delivery system, intended for use in the treatment of artheroscierotic disease of peripheral arteries below the aortic arch,” states CDSCO it its circular. Cordis, in its detailed issue description, has mentioned, “An increase in complaints of Palmaz Genesis Stent dislodgement and associated failure modes was identified for the manufacturing time period of October 2019 through April 2021.”
Cordis has identified through complaint trending analysis which consists of evaluating complaints based on key demographics used to identify potential commonalties. In this case there were manufacturing months with elevated complaint rates which upon further analysis identified the noted time period and product sizes to have an elevated rate compared to the surrounding months.
The potential impacts of stent dislodgment include an intra-procedural delay as the device is exchanged for another of may result in complications such as unplanned percutaneous or surgical intervention, GI tract trauma or perforation.
“The recall does not affect the stents that have been successfully deployed. To date there have been no deaths or serious long term health sequelae, such as strokes, in the use of these involved complaint devices,” stated Cordis.
The medical device alert issued by CDSCO has clarified, “CDSCO has not received any complaints from the market on the issue.”
Cordis Cashel, Ireland has released Distributed Product Risk Assessment Form on May 18, 2022 which explains potential hazard(s) and harm(s) and any immediate and or long range health consequences.
About user interaction with affected device/component, it says, “Balloon expandable stents are intended to be used as a scaffolding within a lesion or stricture to help maintain patency and improve the flow of blood and other body fluids. The Plamaz family of stents are intended for use in the peripheral vascular and the Stent is delivered to the target on a balloon catheter called a Stent delivery system.”
About immediate and long range health consequences, Cordis explains, “If movement of the Stent is detected before or during the procedure, the device can be exchanged resulting in an intra-procedural delay. If the Stent is loose or inaccurately crimped on the balloon the Stent may not be placed where intended in the target vessel. This may result in the need for additional stents to compete the procedure. In the event that none of these percutaneous methods
are visible or successful the Stent may be removed surgically. Therefore, the severity of the potential harm of a Stent that dislodges from the Stent delivery system is ‘critical.’”