Boston Scientific and BD have both initiated recalls of venous stents. According to a US Food and Drug Administration (FDA) medical device recall notice posted 21 May, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and Vici RDS venous stent system. In a recall notification dated 12 May, BD announced that the company has expanded a safety notice issued earlier this year for the Venovo venous stent system.
The FDA announcement regarding the Vici stent reads that Boston Scientific initiated the recall on 12 April “after reports indicate that the stents may migrate or move from where they are initially implanted”. The FDA has labelled this a Class I recall.
Outlining the risks associated with stent migration, the statement reads: “A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls, or other organs. If the stent migrated to the heart, it could cause life-threatening injury.”
There have been 17 complaints and reported injuries related to this issue, the notice states, which adds that no deaths have been reported.
Boston Scientific has asked customers to “immediately discontinue use of the device” and “remove all affected units from inventory and secure them”. The FDA statement urges customers with questions to contact their Boston Scientific representative.
The full FDA medical device recall notice can be found here.
BD has expanded the scope of the urgent medical device safety notice issued on 13 January for the Venovo venous stent system to include all sizes and lots within expiry date.
“BD received reports on the Venovo venous stent system indicating that the proximal end of the stent does not immediately expand upon deployment but remains connected to the stent cushion on the delivery system,” the 12 May statement reads.
It details the potential consequences: “If the proximal end of the stent does not immediately expand upon deployment, over-manipulation or forcing the catheter delivery system, as well as use of other intravascular devices or techniques to assist the stent’s expansion, could potentially have a varying degree of harm associated with it.”
According to BD, potential harm includes the following: “prolonging the procedure, damaging or deformity of the stent, potential vascular injury and/or haemodynamic disruption affecting the blood flow and / or a thrombotic event.” In cases where the stent self-expanded, the notice adds, there is no incremental risk of harm.
While this issue was initially observed on the 14mm diameter product offering, there have been reported complaints across other sizes of the product offering since the initial safety notice was published. To date, BD has received approximately 250 reported complaints across various sizes of the product offering.
The full recall notification can be found here.