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Dive Brief:
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Medtronic has recalled embolization devices collectively linked to reports of 17 injuries and four deaths, the Food and Drug Administration said Tuesday.
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The recall has two elements: Medtronic is removing from the market its Pipeline Vantage 027 devices, which are linked to most of the injuries and all of the deaths, and updating the instructions for using Pipeline Vantage 021 devices.
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The actions follow reports of the flexible, braided tube part of the devices failing to properly attach or stay attached to the blood vessel wall during and after procedures, putting patients at risk of thrombosis, stroke and death.
Dive Insight:
Physicians use Medtronic’s Pipeline Vantage embolization devices to treat bulges in the artery walls of the brain, known medically as aneurysms. Inserted through a small catheter, the devices consist of a braided tube that blocks blood flow to the bulging part of the artery. Diverting blood flow away from the bulging vessel can mitigate the risk posed by unruptured aneurysms.
Medtronic began recalling two products from its Pipeline Vantage range in January, the FDA said in its Class I recall notice. The agency assigns a recall to Class I when there is potential for serious injury or death.
The FDA said there have been 13 reported injuries and four reports of death related to the Pipeline Vantage 027 devices. The product numbers refer to the inner diameters of the microcatheters, 0.027 inches for Pipeline Vantage 027 and 0.021 inches for Pipeline Vantage 021.
As of the end of 2024, Medtronic had received 416 complaints related to the approximately 18,200 Pipeline Vantage 027 units distributed worldwide, according to a Health Canada notice published in February. The Canadian agency said the Vantage 027 devices “appear to exhibit a higher incidence [of] stent braid deformation compared to the pipeline shield.”
Stent braid deformations are typically seen after 6 to 12 months of follow up. The risk of deformation is higher in women, particularly people aged 45 years and younger. Medtronic and the FDA said not to use any affected Pipeline Vantage 027 devices and to remove and quarantine all unused products.
There have been four reported injuries and no reports of death related to the Pipeline Vantage 021 devices, according to the FDA notice. Health Canada said there have been four strokes linked to the devices, adding that Medtronic has received 57 complaints out of approximately 7,400 units distributed. Because the incidence of braid deformation is lower, Medtronic is keeping Pipeline Vantage 021 on the market but updating its manual.