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Sapien 3 Transcatheter Aortic Valve Replacement Devices (TAVRs)

The manufacturer of Sapien 3 Transcatheter Aortic Valve Replacement Devices (TAVRs) has alerted consumers of reports about the device’s balloon exploding during implantation. The balloon malfunction may cause complications when removing the device from the patient’s body. The FDA announced a recall to warn patients of the risk of serious injury or death from TAVRs.

Sapien 3 Transcatheter Aortic Valve Replacement Devices (TAVRs) Lawyers are Ready to Help

Contact our TAVRs Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting TAVRs cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with TAVRs Lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.

What is Sapien 3 Transcatheter Aortic Valve Replacement Devices (TAVRs)?

TAVRs are used to treat aortic stenosis in patients with heart disease and calcific aortic stenosis who are eligible for transcatheter heart valve replacement therapy. TAVR conists of a catheter-based aortic heart valve that is used to insert the valve without the need for open heart surgery. The valve is attached to an expandable frame for support. This delivery system was designed by the manufacturer, Edwards Lifesciences, to streamline the procedure. It has become a popular alternative to open heart surgery.

What is Happening with Sapien 3 Transcatheter Aortic Valve Replacement Devices (TAVRs)?

In July 2019, Edwards Lifesciences notified patients that the balloons used in the delivery system of its TAVR devices have exploded in some patients. The recall affects all TAVR lots manufactured from January 23, 2018 to the present. The company issued an urgent field safety notice to alert users of the risks of stroke, bleeding, and surgical intervention associated with the device. The incidence of burst balloons appears to be triggered by excess inflation volume and rapid inflation conditions according to the manufacturer.

Following the manufacturer’s warning, the FDA issued a Class 1 recall of the TAVRs upon receiving reports of 17 injuries and one death. The recall notes the difficulty of retrieving the device once it has burst. A Class I recall is reserved for products that have the most serious adverse consequences, including death. A warning has also been added to the manufacturer’s label to warn of the risk of balloon rupture.

https://www.medtechdive.com/news/burst-balloons-prompt-safety-alert-on-edwards-sapien-3-ultra-valve-system/559218/

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=174655

Sapien 3 Transcatheter Aortic Valve Replacement Devices Side Effects and Complications

Complications of TAVRs aligners include:

  • Injury;
  • Bleeding;
  • Embolism;
  • Stroke;
  • Surgical intervention; and
  • Death.

Sapien 3 Transcatheter Aortic Valve Replacement Devices Lawyers are Ready to Help

Contact our Sapien 3 Transcatheter Aortic Valve Replacement Device Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Sapien 3 Transcatheter Aortic Valve Replacement Device cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Sapien 3 Transcatheter Aortic Valve Replacement Device Lawyers at our law firm, please call (800) 315-3806or submit an email inquiry.

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