CDSCO issues Medical Device Alert for Cordis palmaz genesis peripheral stent
New Delhi: In line with the Risk Assessment Form released by Cordis Cashel, Ireland, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for PALMAZ GENESIS Peripheral Stent on OPTA PRO .035" Delivery System (PG2990PPX-82178943, PG2990PPX-82211305, PG3990PPS-82182764, PG3990PPX-82212989, PG3990PPX- 82218097).
This Medical Device Alert comes after Cordis released Distributed Product Risk Assessment Form dated 18.05.2022 indicating increased complaint rate for stent dislodgement
The Cordis PALMAZ GENESIS Peripheral Stent on OPTA PRO .035 Delivery System is intended for use in the treatment of atherosclerotic disease of peripheral arteries below the aortic arch.
Cordis noted an increased trend in complaints for stent dislodgement and associated failure modes related to two specific sizes of the PALMAZ GENESIS Stent on OPTA PRO .035 Delivery System that were produced during a particular timeframe (October 2019 to April 2021).
Identified through complaint trending analysis which consists of evaluating complaints based on key demographics used to identify potential commonalities. 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 when compared to the surrounding months.
The potential impacts of stent dislodgement include an intra-procedural delay as the device is exchanged for another or may result in complications such as: unplanned percutaneous or surgical intervention, GI tract trauma or perforation.
Further, the safety alert stated that the recall is being undertaken due to stent dislodgement prior to or during placement and does not affect PALMAZ GENESIS stents that have been successfully deployed.
However, it is worth noting that the usage of these involved complaint devices has not yet resulted in any fatalities or major long-term health consequences, such as strokes.
In addition, the safety notice added that 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 Palmaz 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.
In accordance with the immediate and long Range Health Consequences, the notice stated that 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 complete the procedure." the notice added.
If none of these percutaneous techniques work or are visible, the stent may be surgically removed. The severity of the possible damage caused by a stent that separates from the stent delivery system is therefore crucial.
The CDSCO further stated that the market has not voiced any complaints about this matter.
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