Last Updated on January 14, 2024 by The Health Master
Download the Medical Device Alert dated 21-06-2022: The Central Drug Standard Control Organisation (CDSCO) issued a medical device alert on 21-06-2022 on certain batches of peripheral stents manufactured by US-based medical technology firm Cordis following the company’s raised alarm on the increasing complaint rate for the product.
A medical device alert has been issued for the Cordis Palmaz Genesis peripheral stent on the Opta Pro .035 delivery system, intended for use in the treatment of atherosclerotic disease of peripheral arteries below the aortic arch.
Cordis noted an increasing trend in complaints about stent dislodgement and associated failure modes related to two specific sizes of the device that were produced during a particular timeframe of October 2019 to April 2021.
It is 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 compared to the surrounding months.
The potential impacts of stent dislodgement 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.
CDSCO said that it has not received any complaints from the market on the issue.
The company said there have been no deaths or serious long-term health sequelae, such as strokes, in the use of these compliant devices.
It further elaborates that balloon-expandable stents are intended to be used as scaffolding within a lesion or stricture to help maintain patency and improve the flow of blood and other bodily 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.
If the 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.
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,” it added.
While the issue was escalated by the product safety clinician to the company in March 2021, the company said that the investigation concluded that there was no evidence to show that the customer complaints were related to manufacturing deficiencies.
However, in March 2022, the product safety clinician presented data that identified an increase in complaints about 2021, and in April 2022, the decision was made to initiate a risk assessment.
In a total of 105 complaints about the period from January 2016 to February 2022, in 63 events the device was identified to have a rate above the expected occurrence as per the norms.
Production of stents with two product codes was stopped until corrective actions are implanted, the company said in its filing with the US government.
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